Eating disorders often start at a younger age, but they don’t solely affect this population. Recognizing this, virtual eating disorder support company Equip announced Tuesday that it is now treating adults as well as adolescents. The company also announced an investment from General Catalyst, which helped expand its platform to adults. The amount was not disclosed.
“There is a very pervasive, really dense stereotype that eating disorders only affect 15- to 25-year-old thin, White girls,” said Dr. Erin Parks, chief clinical officer and co-founder of Equip, in an interview. “That is true, it does affect them. But it is not only them.”
She added that because so few people have access to treatment, many older adults have had their eating disorder for a very long time and need support.
San Diego-based Equip, which was founded in 2019, previously focused on those ages 6 to 24. The startup is now expanding to serve people of all ages. The virtual company operates in all 50 states and is in-network with several insurance companies, including Aetna, Elevance, Optum, Cigna and UnitedHealthcare. It connects patients with a care team that includes a therapist, dietitian, physician and peer and family mentor.
Different ages require different kinds of treatment, according to Parks. With its younger patients, the company uses family-based treatment, in which the family is brought in to help care for the patient. For adults, the company is using a method called enhanced cognitive behavioral therapy, which is a highly individualized treatment that addresses thoughts, feelings and behaviors affecting the patient’s eating disorder.
Parks said that when it comes to adults, individual treatment is often the best way to go because they may not have a support group. Sometimes when adults have been sick for a long time, they’ve “pushed away” a lot of their family and peers, or they may be too busy with work to build that support group.
There are other virtual solutions for eating disorders as well, including Arise and Within. Arise offers coaching with a care advocate who has lived experience with an eating disorder, therapy, nutrition counseling, group support and psychiatry. Within provides access to a care team that includes dietitians, therapists, nurses and peers.
The expansion to adults was powered by a recent investment by General Catalyst. In total, Equip has raised more than $75 million. With the funding, the company brought on a new president, Nikia Bergan. It also updated its technology and trained its providers in treating adults. In addition, it’s planning to use the funding to gain more Medicaid contracts, Parks said.
Equip considers itself an alternative to brick-and-mortar eating disorder treatments, which often require patients to stay at the treatment facility for a certain period. Parks said the benefit of a virtual program is that patients can be treated as they live their normal lives.
“[If you take] someone out of their life and give them a bunch of skills, then all of the sudden they plop back into their life and have all these triggers that they aren’t equipped to deal with,” Parks argued. “One of the great things about getting treatment while still being able to go to school, still being able to go to your job, still being able to parent your kids, is that you get to work with your providers on your real-life triggers as they come up.”
Parks is likely looking to replicate the positive results it claims to have achieved in the adolescent population in this new, adult population. In its annual outcomes report published earlier this year, the company cited that 81% of its adolescent patients reached or maintained their target weight within one year.
Photo credit: Bohdan Skrypnyk, Getty Images
The commercial market has been slower to adopt value-based care than the public market, but there are ways to move the process along successfully, executives said Monday.
During a panel at the Oliver Wyman Health Innovation Summit 2023 held in Chicago, healthcare leaders discussed the challenges and opportunities in advancing value-based care in commercial health plans. The panelists were Mark Hansberry, senior vice president and chief marketing officer of HealthPartners; Ellen Kelsay, president and CEO of Business Group on Health; and Tiffany Albert, senior vice president of health plan business at Blue Cross Blue Shield of Michigan.
Bloomington, Minnesota-based HealthPartners, which is an integrated healthcare organization serving more than 1.8 million members, has had some success with value-based care in the commercial space, Hansberry claimed. He shared five rules for scaling value-based care in the commercial market:
1. Payers and providers in a value-based arrangement need to have a shared understanding of what value is for patients, Hansberry said.
“You have to have a universal definition of what value means so that when clinicians look at you as a payer … they need to acknowledge that what you’re saying a clinical outcome is is actually a good clinical outcome, a good measure of performance,” he stated.
2. It’s important to ensure that the providers in the value-based arrangement are able to and willing to take the risk associated with value-based care.
“Most care systems weren’t built to actually manage risk,” Hansberry said. “That wasn’t their job. Their job was to take care of sick people. Now we’re asking them to do something else. How do you actually support those individuals on that journey?”
3. Payers need to support providers engaging in value-based care with “real-time, actionable data and consultation,” Hansberry said.
“It’s not just a data dump or a big Excel file that you pass over and you say good luck with it,” he stated. “Because, by the way, if they perform well in those value-based contracts, you do too as a payer. You want them to perform well. So you want to provide them with good, insightful, actionable data that’s risk-adjusted, that is connected to their practice — not just an amorphous health system — but to their practice so they can take action on those insights. But then you also want to supplement that with that consultation along the way.”
4. The incentives in the value-based contract must be aligned to “enable that [provider] to reap the benefits of the value that they’re creating for those members,” according to Hansberry.
5. Ultimately, a value-based contract comes down to trust between all the parties. But Hansberry noted that this is easier for HealthPartners as an integrated health system.
“We’re fortunate because we’re both a health plan and a care system,” he said.
He added that success in value-based care doesn’t happen overnight, which is partially why it’s difficult to scale.
“It takes time to build trust,” Hansberry stated.
Photo: atibodyphoto, Getty Images
– APHEXDA is the first innovation in stem cell mobilization for multiple myeloma to be approved in the U.S. in a decade –
– One dosage of APHEXDA plus filgrastim enabled a majority of patients to achieve the collection goal of ≥ 6 million hematopoietic stem cells among a contemporary population of multiple myeloma patients –
– Management to hold conference call on Tuesday, September 12, 2023 at 8:00 a.m. U.S. EDT –
TEL AVIV, Israel, Sept. 11, 2023 /PRNewswire/ — BioLineRx Ltd. (NASDAQ/TASE: BLRX), a commercial stage biopharmaceutical company focused on certain cancers and rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved APHEXDA™ (motixafortide) in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma. APHEXDA is administered by injection, for subcutaneous use.
Experience the full interactive Multichannel News Release here: https://www.multivu.com/players/English/9174951-biolinerx-fda-approval-aphexda/
Multiple myeloma is the second most-common hematologic malignancy. Autologous stem cell transplantation (ASCT) is part of the standard of care treatment paradigm for multiple myeloma and delivers prolonged survival for patients with this cancer type.1 The success of ASCT depends on adequate mobilization of stem cells during the treatment process. The American Society for Transplantation and Cellular Therapy (ASTCT) guidelines recommend a collection target of 3-5 x 106 CD34+ cells/kg.2 Additionally, collection of a sufficient number of stem cells to perform two transplantations is recommended.2-5 Historically, depending on induction regimens and mobilization strategies, up to 47% of patients have had challenges collecting target numbers of hematopoietic stem cells for ASCT after one apheresis session.6-7
“Greater numbers of patients with multiple myeloma are candidates for autologous stem cell therapy; however, achieving target collection goals can be difficult in some patients given modern barriers, including the treatment of older patients and use of contemporary induction regimens,” said John DiPersio, MD, PhD, primary investigator for the GENESIS trial and
Professor of Medicine, Pathology and Immunology and Director of the Center for Gene and Cellular Immunotherapy at Washington University School of Medicine in St. Louis. “Innovation in this area of medicine has been needed, and today’s approval of APHEXDA addresses the demand for new therapies that can meet today’s challenges by delivering more reliability in stem cell mobilization, versus filgrastim alone, with fewer days of apheresis sessions and fewer doses of filgrastim for people living with this cancer.”
The FDA approval of APHEXDA is based on results from the 2-part, Phase 3 GENESIS trial, a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of APHEXDA (motixafortide) plus filgrastim, compared to placebo plus filgrastim, for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients. Part 1 was a single center, lead-in, open-label study involving 12 patients treated with motixafortide plus filgrastim designed to ascertain the dose. Part 2 involved 122 patients who were randomized 2:1 in a double-blind, placebo-controlled, multicenter study.8
The assessment of CD34+ cells was performed by central and local laboratories. Central laboratory assessments were used for the efficacy results. Local laboratory results were used for clinical treatment decisions. APHEXDA plus filgrastim enabled 67.5% of patients to achieve the stem cell collection goal of ≥ 6 × 106 CD34+ cells/kg within two apheresis sessions, versus 9.5% for the placebo plus filgrastim regimen, as measured by central laboratory.9 Additionally, 92.5% of patients reached the stem cell collection goal in up to two apheresis sessions in the APHEXDA arm and 21.4% in the placebo arm, as measured by local laboratories.9 Local laboratory data were used for a sensitivity analysis. The data are descriptive and were not statistically powered nor prespecified. The information should be cautiously interpreted.
In GENESIS, the safety was evaluated in 92 patients with multiple myeloma who received APHEXDA 1.25 mg/kg subcutaneously plus filgrastim, and 42 patients who received placebo plus filgrastim. Serious adverse reactions occurred in 5.4% of patients receiving APHEXDA plus filgrastim. These reactions included vomiting, injection site reaction, hypersensitivity reaction, injection site cellulitis, hypokalemia and hypoxia. The most common adverse reactions occurring in GENESIS (incidence >20%) were injection site reactions (pain, erythema and pruritus), pruritus, flushing, and back pain.9
“Given the strong efficacy data shown in the GENESIS trial, which included patients who are representative of the current multiple myeloma patient population, we believe APHEXDA will play a critical role in addressing unmet needs and introduce a new treatment paradigm for this challenging cancer,” said Philip Serlin, Chief Executive Officer of BioLineRx Ltd. “The company is working relentlessly to make this important innovation in stem cell mobilization available to appropriate patients, their physicians and transplant teams.”
“FDA approval of APHEXDA, the company’s first approved therapeutic, is a tremendously exciting and important moment in our history and validates our drug development programs,” said Ella Sorani, PhD, Chief Development Officer of BioLineRx Ltd. “We would like to thank all of the patients and families who have contributed to the research and development of APHEXDA.”
Increased age, as well as exposure to lenalidomide-containing induction regimens, including 3-4 drug combination regimens, have been associated with impaired stem cell mobilization.2-3 The GENESIS study included patients considered representative of the typical multiple myeloma population undergoing ASCT, with a median age of 63 years and with ~70% of patients in both arms of the trial receiving lenalidomide-containing induction therapy.8 In this contemporary population, patients in the APHEXDA plus filgrastim arm were able to mobilize more than four times the amount of stem cells with a single dose over a 24-hour period compared with placebo plus filgrastim.8
BioLineRx expects to make APHEXDA available later this month. For further information about APHEXDA, please see the Important Safety Information below and the full Prescribing Information, and visit www.APHEXDA.com.
APHEXDA Investor Conference Call
The Company will host an investor conference call on September 12, 2023 at 8:00 a.m. EDT featuring remarks by Philip Serlin, Chief Executive Officer.
To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until September 14, 2023; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.
About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that affects some white blood cells called plasma cells, which are found in the bone marrow. When damaged, these plasma cells rapidly spread and replace normal cells in the bone marrow. According to the American Cancer Society, in 2023, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma, and nearly 13,000 people will die from the disease in the U.S.10 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems, or infections.
About Autologous Stem Cell Transplantation
Autologous stem cell transplantation (ASCT) is part of the standard treatment paradigm for a number of blood cancers, including multiple myeloma. In the U.S., as many as 8,000 ASCTs are performed each year in patients with multiple myeloma.11 The current ASCT standard of care includes 4-6 cycles of induction therapy (an initial drug-combination regimen to position the patient for as deep a treatment response as possible). To begin the stem cell mobilization process, a patient will receive a daily dose of filgrastim (G-CSF) for four days. Daily doses of filgrastim will continue until the target collection goal is met with the addition of up to four daily doses of plerixafor as needed.12 For patients unable to mobilize sufficient numbers of cells for harvesting during this primary mobilization phase, rescue therapy may be carried out followed by an additional number of apheresis sessions as necessary.2
About the GENESIS Trial
GENESIS (NCT 03246529) is a 2-part, Phase-3, randomized, double-blind, placebo-controlled, multicenter study evaluating the safety and efficacy of APHEXDA (motixafortide) plus filgrastim (G-CSF), compared to placebo plus filgrastim, for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients. Part 1 was a single center, lead-in, open-label study involving 12 patients treated with motixafortide plus filgrastim designed to ascertain the dose. Part 2 involved 122 patients who were randomized 2:1 in a double-blind, placebo-controlled, multicenter study.8
The primary objective of the study was to evaluate if one dose of motixafortide plus filgrastim is superior to placebo plus filgrastim in the ability to mobilize ≥ 6 million CD34+ cells in up to two apheresis sessions. A key secondary objective of the study was to evaluate if one dose of motixafortide plus filgrastim is superior to placebo plus filgrastim in the ability to mobilize ≥ 6 million CD34+ cells in one apheresis session.8
The study met the primary endpoint with a high degree of statistical significance (p<0.0001). The assessment of CD34+ cells was performed by central and local laboratories. Central laboratory assessments were used for the efficacy results. Local laboratory results were used for clinical treatment decisions. APHEXDA plus filgrastim enabled 67.5% of patients to achieve the cell collection goal of ≥ 6 × 106 CD34+ cells/kg in up to two apheresis sessions with a single administration, versus 9.5% for the placebo plus filgrastim regimen, as measured by central laboratory.9 Additionally, 92.5% of patients reached the stem cell collection goal in up to two apheresis sessions in the APHEXDA arm and 21.4% in the placebo arm, as measured by local laboratories.13 Local laboratory data were used for a sensitivity analysis. The data are descriptive and were not statistically powered nor prespecified. The information should be cautiously interpreted.
The safety of APHEXDA was evaluated in 92 patients with multiple myeloma who received APHEXDA 1.25 mg/kg subcutaneously plus filgrastim and 42 patients who received placebo plus filgrastim for mobilization of hematopoietic stem cells for collection and apheresis. Serious adverse reactions occurred in 5.4% of patients receiving APHEXDA plus filgrastim. Serious adverse reactions included vomiting, injection site reaction, hypersensitivity reaction, injection site cellulitis, hypokalemia and hypoxia. The most common adverse reactions occurring in GENESIS (incidence >20%) were injection site reactions (pain, erythema, and pruritus), pruritus, flushing and back pain.9
Please see important safety information below.
About APHEXDA™
APHEXDA (motixafortide) is a CXCR4 antagonist with long receptor occupancy (greater than 72 hours) that, in combination with filgrastim (G-CSF), enables mobilization of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous stem cell transplantation in patients with multiple myeloma.9
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION
APHEXDA is indicated in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
APHEXDA is contraindicated in patients with a history of serious hypersensitivity reactions to motixafortide.
WARNINGS AND PRECAUTIONS
- Anaphylactic Shock and Hypersensitivity Reactions: Anaphylactic shock and hypersensitivity reactions have occurred. Premedicate all patients with a triple drug premedication regimen that includes an H1-antihistamine, an H2 blocker, and a leukotriene inhibitor approximately 30-60 minutes prior to each dose of APHEXDA. Administer APHEXDA in a setting where personnel and therapies are immediately available for treatment of anaphylaxis and other systemic reactions. Monitor patients for 1 hour following APHEXDA administration and manage reactions promptly. Patients receiving negative chronotropic drugs (e.g., beta-blockers) may be more at risk for hypotension in the event of a hypersensitivity reaction and these drugs, when appropriate, should be replaced with non-chronotropic drugs.
- Injection Site Reactions: Injection site reactions (73%) including pain (53%), erythema (27%), and pruritus (24%) have occurred. Severe reactions occurred in 9% of patients. Premedicate with an analgesic premedication (e.g., acetaminophen) prior to each APHEXDA dose. Use analgesic medication and local treatments post-dose, as needed.
- Tumor Cell Mobilization in Patients with Leukemia: For the purpose of hematopoietic stem cell (HSC) mobilization, APHEXDA may cause mobilization of leukemic cells and subsequent contamination of the apheresis product. Therefore, APHEXDA is not intended for HSC mobilization and harvest in patients with leukemia.
- Leukocytosis: Administering APHEXDA in conjunction with filgrastim increases circulating leukocytes as well as HSC populations. Monitor white blood cell counts during APHEXDA use.
- Potential for Tumor Cell Mobilization: When APHEXDA is used in combination with filgrastim for HSC mobilization, tumor cells may be released from the marrow and subsequently collected in the leukapheresis product. The effect of potential reinfusion of tumor cells has not been well-studied.
- Embryo-fetal Toxicity: Based on its mechanism of action, APHEXDA can cause fetal harm. Advise pregnant women of the potential risk to the fetus. Verify pregnancy status in females of reproductive potential prior to initiating treatment with APHEXDA and advise use of effective contraception during treatment and for 8 days after the final dose.
ADVERSE REACTIONS
The most common adverse reactions (incidence >20%) in patients treated with APHEXDA were injection site reactions [73%, including pain (53%), erythema (27%), pruritus (24%)]; pruritus (38%); flushing (33%); back pain (21%).
USE IN SPECIFIC POPULATIONS
Pregnancy: Please see the important information in Warnings and Precautions under Embryo-fetal Toxicity.
Lactation: There are no data on the presence of motixafortide in human milk, the effects on the breastfed child, or the effects on milk production. Advise females that breastfeeding is not recommended during treatment with APHEXDA and for 8 days after the final dose.
Pediatric Use: The safety and effectiveness of APHEXDA have not been established in pediatric patients.
Please see the accompanying full Prescribing Information.
About BioLineRx
BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a commercial stage biopharmaceutical company pursuing life-changing therapies for certain cancers and rare diseases. The company’s first approved product is APHEXDA™ (motixafortide) with an indication in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma. BioLineRx is advancing a pipeline of investigational medicines for patients with sickle cell disease, pancreatic cancer, and other solid tumors. Headquartered in Israel, and with operations in the U.S., the company is driving innovative therapeutics with end-to-end expertise in development and commercialization, ensuring life-changing discoveries move beyond the bench to the bedside.
Learn more about who we are, what we do, and how we do it at www.biolinerx.com, or on Twitter and LinkedIn.
Forward Looking Statement
Various statements in this release concerning BioLineRx’s future expectations constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as “anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” and “would,” and describe opinions about future events. These include statements regarding management’s expectations, beliefs and intentions regarding, among other things, the potential benefits of APHEXDA, the timing of the launch of APHEXDA and the plans and objectives of management for future operations and expectations and commercial potential of motixafortide. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause BioLineRx’s actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing, progress and results of BioLineRx’s preclinical studies, clinical trials and other therapeutic candidate development efforts; BioLineRx’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; whether the clinical trial results for APHEXDA will be predictive of real-world results; BioLineRx’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of BioLineRx’s therapeutic candidates, including the degree and pace of market uptake of APHEXDA for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients; whether access to APHEXDA is achieved in a commercially viable manner and whether APHEXDA receives adequate reimbursement from third-party payors; BioLineRx’s ability to establish and maintain corporate collaborations; BioLineRx’s ability to integrate new therapeutic candidates and new personnel; the interpretation of the properties and characteristics of BioLineRx’s therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx’s business model and strategic plans for its business and therapeutic candidates; the scope of protection BioLineRx is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of BioLineRx’s expenses, future revenues, capital requirements and its needs for and ability to access sufficient additional financing, including any unexpected costs or delays in the commercial launch of APHEXDA; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx’s industry; statements as to the impact of the political and security situation in Israel on BioLineRx’s business; and the impact of the COVID-19 pandemic and the Russian invasion of Ukraine, which may exacerbate the magnitude of the factors discussed above. These and other factors are more fully discussed in the “Risk Factors” section of BioLineRx’s most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 22, 2023. In addition, any forward-looking statements represent BioLineRx’s views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.
- Kumar SK, et al. Blood. 2008;111(5):2516-2520.
- Giralt S, et al. Biol Blood Marrow Transplant. 2014;20(3):295-308.
- Giralt S, et al. Leukemia. 2009;23(10):1904-1912.
- Giralt S, et al. Biol Blood Marrow Transplant. 2015;21(12):2039-2051.
- Tricot G, et al. Blood. 1995;85(2):588-596.
- Edmisson J, et al. Poster presented at: 64th American Society of Hematology Annual Meeting and Exposition; December 10-13, 2022; New Orleans, LA.
- DiPersio JF, et al. Blood. 2009; 113(23):5720-6.
- Crees, ZD, et al. Future Oncology. 2019;15(30):3555-3563.
- APHEXDA. Prescribing Information. BioLineRx Ltd; 2023.
- American Cancer Society. Key Statistics About Multiple Myeloma. Atlanta, Ga: American Cancer Society; 2023.
- Auletta JJ, et al. Current use and outcome of hematopoietic stem cell transplantation: CIBMTR US summary slides. 2021.
- Multiple Myeloma Research Foundation. Multiple Myeloma Treatment Overview. Norwalk, Conn.: Multiple Myeloma Research Foundation; 2019.
- BioLineRx. Data on File #1005. June 29, 2023.
SOURCE BioLineRx Ltd.
Psychiatrist Dr. Mark Johnston as CMO and senior pharmaceutical commercialization expert Greg Rutherford as CCO accelerates APEX’s ability to bring new drugs to market.
VANCOUVER, BC, Aug. 10, 2023 /PRNewswire/ – Apex Labs Ltd. (APEX or the Company), a pharmaceutical company transforming the standard of mental health care with clinically proven psilocybin treatments, announces the addition of two new executives to the c-suite, psychiatrist Dr. Mark Johnston, MD, FRCPC, as Chief Medical Officer and Greg Rutherford as Chief Commercial Officer.
Dr. Johnston, APEX CMO has been practicing psychiatry for over 20 years running a private Veteran-focused network of mental health clinics. He has been the principal investigator on over 25 central nervous system clinical trials, including trials in depression, bipolar disorder, ADHD, OCD, and Alzheimer’s dementia. Most recently he was the Medical Director of CNS Research at Centricity Clinical Trials.
“Our current treatment options for PTSD and depression are inadequate at best,” says Dr. Johnston, CMO. “Although we can have success stories with available medications, just as often we find only partial responses or intolerable side-effects. New options are desperately needed for this population, and APEX’s pipeline of psychedelic treatments has huge potential.”
Greg Rutherford, APEX CCO is a senior pharmaceutical commercialization expert with over 25 years of proven global experience optimizing multiple new drug launches, product life cycles and commercial strategy. His pharmaceutical and healthcare experience includes senior commercial roles at Johnson & Johnson, Roche, GSK and Lilly.
“With decades of experience recognizing market opportunities with emerging and novel drug assets, I am extremely excited to be part of the APEX team addressing the significant unmet clinical need within PTSD, depression and anxiety,” says Greg Rutherford, CCO. “The current standard of care treatments are sub-optimal and not meeting the needs of many patients and I see the tremendous potential for improved outcomes with psilocybin.”
Dr. Peter Tomlinson, APEX’s Co-Founder and current CMO will be shifting to the role of Chief Technical Officer to oversee the company’s clinical, regulatory and GMP manufacturing strategies as we approach the launch of multiple statistically powered phase 2b clinical trials in 2023/2024.
“The addition of a seasoned practicing psychiatrist with robust clinical trial execution experience and a global pharmaceutical commercialization expert highlights our commitment to a rigorous clinical trial strategy and optimized drug portfolio,” says Tyler Powell, APEX Co-Founder and CEO. “Exciting times ahead for the APEX team.”
About APEX Clinical Studies:
PATHFINDER-52 and SUMMIT-90 are statistically powered multi-center randomized, double-blind, placebo-controlled phase 2b studies leveraging microdose and macrodose psilocybin drug assets with patient pre-screening underway.
APEX intends to optimize the two unique drug assets to target mild, moderate and severe disease across intended indications, addressing significant unmet clinical need.
PATHFINDER-52 evaluates multiple regular doses of APEX-52 microdose, take-home orally administered synthetic psilocybin drug product in treating depression and anxiety in patients with diagnosed Post-Traumatic Stress Disorder (PTSD), recruiting 294 subjects, the world’s largest take home psilocybin clinical trial approved to date.
SUMMIT-90 evaluates multiple doses of APEX-90 macrodose psilocybin administered in-clinic with assisted psychotherapy for the treatment of severe depression in patients with diagnosed PTSD, recruiting 160 patients in Canada. SUMMIT-90’s primary indication being studied is severe depression within diagnosed PTSD and secondary indications include standalone PTSD symptoms, chronic pain, and anxiety.
About Apex Labs Ltd.
APEX is a patient-driven pharmaceutical company focused on revolutionizing the standard of mental health care for patients with clinically proven psilocybin treatments. By bringing data supported, clinically evaluated drugs to market for depression and anxiety in PTSD, APEX’s strategy is focused on developing pharmaceutical products through phased clinical programs evaluating safety and efficacy across multiple indications, alongside a robust early access program.
APEX sees Veterans as a patient base with the severest unmet need and strong mental healthcare infrastructure. APEX is supporting Veteran patients first and expanding to broader global patient communities.
Visit apexlabs.com for more information and follow APEX on LinkedIn, Twitter and Instagram
Forward-Looking Statement
This release contains certain “forward looking statements” and certain “forward-looking information” as defined under applicable Canadian securities laws. Forward-looking statements and information can generally be identified by the use of forward-looking terminology such as “may”, “will”, “expect”, “intend”, “estimate”, “anticipate”, “believe”, “continue”, “plans” or similar terminology. Forward-looking statements and information are based on forecasts of future results, estimates of amounts not yet determinable and assumptions that, while believed by management to be reasonable, are inherently subject to significant business, economic and competitive uncertainties and contingencies. Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict, that may cause the Company’s actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out here in, including but not limited to: Permit approvals from Health Canada, the Drug Enforcement Administration (DEA), and US customs, Health Canada’s CTA amendments, the Company evaluating the safety and efficacy of APEX-52 (psilocybin) and APEX-90 in treating depression in Veterans with depression in post-traumatic stress disorder; statements related to APEX-52 and APEX-90, including manufacturing, dosing, and trial details; statement’s made by the Company’s CEO with respect to the Company’s efforts to enter the US market and file an IND,; statements from the Company’s CSO relating to their drug development and secondary manufacturer; statement’s made relating to Canadian Veteran patient’s taking APEX-52 in the comfort of their own home; the potential impact of epidemics, pandemics or other public health crises, including the current outbreak of the novel coronavirus known as COVID-19 on the Company’s business, operations and financial condition, the successful integration of technology, the inherent risks involved in the general securities markets; uncertainties relating to the availability and costs of financing needed in the future; the inherent uncertainty of cost estimates and the potential for unexpected costs and expenses, currency fluctuations; regulatory restrictions, liability, competition, loss of key employees and other related risks and uncertainties. The Company undertakes no obligation to update forward-looking information except as required by applicable law. Such forward-looking information represents managements’ best judgment based on information currently available. No forward-looking statement can be guaranteed and actual future results may vary materially. Accordingly, readers are advised not to place undue reliance on forward-looking statements or information.
SOURCE Apex Labs Ltd.
Published: Aug. 7, 2023 at 9:28 a.m. ET
By Colin Kellaher
Poseida Therapeutics has signed a $50 million deal with Japan’s Astellas Pharma aimed at advancing the clinical-stage biopharmaceutical company’s cancer cell-therapy work.
San Diego-based Poseida on Monday said Astellas will invest $25 million for an 8.8% stake in the company, buying more than 8.33 million shares at $3 each,…
By Colin Kellaher
Poseida Therapeutics has signed a $50 million deal with Japan’s Astellas Pharma aimed at advancing the clinical-stage biopharmaceutical company’s cancer cell-therapy work.
San Diego-based Poseida on Monday said Astellas will invest $25 million for an 8.8% stake in the company, buying more than 8.33 million shares at $3 each, 84% above Friday’s closing price of $1.63.
Astellas will also pay $25 million for a right of exclusive negotiation and first refusal to license Poseida’s P-MUC1C-ALLO1 allogeneic CAR-T cell therapy in development for multiple solid tumor indications.
Poseida said it is granting Astellas a board observer seat, which includes the ability to attend scientific advisory board meetings, and certain notice rights related to any potential change of control.
Trading in Poseida shares was halted premarket on Monday.
Write to Colin Kellaher at colin.kellaher@wsj.com
SAINT-CLOUD, France, June 13, 2023 /PRNewswire/ — Denis DELVAL, President & CEO of the Ethypharm Group, announces the appointment of Xavier LASSERRE as Chief Commercial Officer (CCO), effective June 12, 2023.
Xavier LASSERRE has a strong experience and expertise in the pharmaceutical industry, particularly in the European markets, both in the retail and hospital sectors.
He holds an advanced degree in Neuroscience and is a graduate of ESCP (Paris Business School). With over 25 years of experience, he has demonstrated remarkable leadership in various roles, contributing significantly to the success and transformation of businesses under his responsibility. Xavier’s most recent position was as Head of Commercial Operations at Zentiva Group, where he was a valued member of the Executive Committee, overseeing affiliate General Managers and export activities.
Xavier joins the Executive Committee of Ethypharm and leads the company’s head of affiliates UK, China, France, Spain, Germany, and Italy. Additionally, Xavier will oversee the distribution and licenses businesses, as well as the Business Development functions.
“I’ am thrilled to join Ethypharm as the new Chief Commercial Officer. Ethypharm has a strong commitment to improving patient lives, and I am eager, with the talented team at Ethypharm, to contribute to the company’s growth and success. I look forward to leading the commercial strategy, driving market expansion, and fostering collaborations to bring our valuable treatments to more patients worldwide.” Says Xavier LASSERRE.
Denis DELVAL – CEO & President of the Group Ethypharm, expresses confidence in Xavier’s ability to drive the company’s commercial growth and stated, “We are delighted to welcome Xavier to the Ethypharm Group. His extensive experience and proven track record in the pharmaceutical industry make him an ideal fit for our organization. We are confident that Xavier’s commercial talent and expertise combined with his leadership will contribute significantly to our continued success. We are excited about this new chapter and look forward to working together towards achieving our goals and further strengthening our position in the market.”
About Ethypharm
Ethypharm is a European pharmaceutical company focused on the Central Nervous System and Critical Care treatments. Ethypharm markets its drugs directly in Europe and China, and with partners in North America and the Middle East. The Group employs more than 1,500 people, mainly in Europe and China. Ethypharm works closely with authorities and healthcare professionals to ensure the appropriate use of and access to its medicines, by as many people as possible.
For more information, visit www.ethypharm.com and follow us on LinkedIn
Contact Media
Avril PONNELLE | Group Communication Manager
Ethypharm | 194 Bureaux de la Colline | 92213 Saint-Cloud Cedex – France
[email protected] | www.ethypharm.com
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SOURCE Ethypharm Digital Therapy
DANVILLE — The Danville Area Planning and Zoning Commission this week will consider a special-use permit for another cannabis dispensary proposed in Danville.
MariWorks, LLC of Chicago is requesting a special-use permit to operate an adult use cannabis dispensary at 500 Eastgate Drive.
The commission meets at 5:15 p.m. Thursday at the Robert E. Jones Municipal Building, 17 W. Main St.
MariWorks was one of two licensees the state selected through a lottery for additional cannabis dispensary licenses for this area. The other was Parkway Dispensary which is building in Tilton after the city of Danville voted against its request to build off Lynch Road. This area of the city already has Sunnyside dispensary and the planned Seven Point dispensary across the road at 380 Eastgate Drive near the Econo Lodge.
MariWorks is proposing to construct a dispensary and parking lot at 500 Eastgate Drive. The site is around the curve, on the south side of Danville Metal Stamping. The land is where there was a previous modular home business site near Interstate 74.
The 7 acres of land is in the B3 general commercial business zoning district.
According to the permit application, a portion of the vacant property will be used for a cannabis retail facility, with the rest of the property for future development.
For development to occur at the location, the public sanitary line must be extended from the north to the projected development. Improvements to site drainage likely will be required.
The nuEra Danville site would join other locations already in Champaign, Urbana, Chicago, Aurora, East Peoria and Pekin.
Danville Metal Stamping is in opposition of the special-use permit and asks that it be denied.
According to Executive Vice President of Danville Metal Stamping Gardner Peck, the business has a facility housing approximately 175 employees operating three shifts at 400 Eastgate Drive.
The proposed cannabis dispensary would be located across Jones Road from Danville Metal Stamping.
“Eleven hundred feet north on Eastgate Drive from the proposed location is the proposed location of Seven Point’s dispensary at 380 Eastgate Drive. Nine hundred and fifty feet across Lynch Road and to the northwest on Lynch Drive is Sunnyside cannabis dispensary (369 Lynch Drive). Granting this permit would result in three separate dispensaries within 2,200 feet of each other. This concentration is not beneficial for the industrial park,” Peck stated.
“It is likely that a third facility directly across the road from our facility would result in Danville Metal Stamping feeling the need to add even more security cameras at our facility to ensure the safety and security of Danville Metal Stamping employees and property,” he continued.
Peck stated, “If a special-use permit is granted for 500 Eastgate Drive, the potential for issues would increase as a result of additional foot traffic along Eastgate Drive and Jones Road where there are no sidewalks and a high number of large trucks making deliveries and picking up from Danville Metal Stamping and Nutrien AG Solutions located at 3400 Jones Road. This will create a very dangerous situation and considerable cost would need to be incurred by the city to ensure all vehicles, as well as pedestrians, can safety transverse the area without being at significant risk.”
It’s no secret that hospitals and health systems have been facing severe financial woes in the past couple years. These money problems have forced many providers to make what they likely felt were tough but necessary choices — such as shuttering underperforming service lines, laying off staff and using debt collection agencies to obtain payment from patients.
Some of these tactics have even invited negative scrutiny. However, a new report argued that commercial payers should shoulder some of the blame when it comes to how hospitals are managing their dire financial circumstances.
Compared to government payers, commercial payers take significantly longer to pay hospitals and deny claims at a higher frequency — often without a justifiable reason to do so — according to the report published by consulting firm Crowe. These delays mean that hospitals are waiting longer than they need to receive commercial payments — during a time when they need cash flow to be expedited, not needlessly delayed, the report said.
Crowe analyzed data from the more than 1,800 hospitals that use its revenue cycle analytics platform and found that about 45% of a typical hospital’s patient population is covered by a commercial health insurance carrier.
Commercially insured patients have conventionally been thought of as hospitals’ preferred population. This is because hospitals can negotiate prices with commercial payers, and these payers usually pay higher rates than government payers like Medicare and Medicaid. For the average net revenue per inpatient case, commercial plans pay $18,156.50 compared to $14,887.10 from Medicare. For outpatients, commercial plans pay $1,606.86 for the average patient case, compared to $707.30 paid by Medicare.
Reimbursement rates may be higher among commercial payers, but getting them to pay in a timely manner is an entirely different story, per the report. During the first quarter of this year, commercial payers initially denied 15.1% of inpatient and outpatient claims compared to 3.9% for Medicare over the same period, according to the report.
Crowe analyzed the claim denial category of prior authorization and precertification denials. These occur when a payer denies a claim based on their decision that a provider did not get prior approval for care before it was delivered or that the care rendered wasn’t necessary based on the patient’s medical diagnosis.
Last year, the prior authorization/precertification denial rate for inpatient claims among commercial payers was 2.8%, up from 2.4% in 2021. This rate increased to 3% during the first three months of 2023, but the denial rate for traditional Medicare was just 0.2% during the same period.
Another claim denial category that the report examined is the request for information (RFI). RFI denials happen when a payer decides not to process a claim because it is missing some type of required documentation, such as a signature or copy of the medical record. In this category, commercial payers’ denial rate is 12 times higher than Medicare, the report found.
Most of the claims that commercial payers deny eventually get paid. However, the administrative effort required for hospitals to turn an initially-denied claim into a payment costs a good deal of time and money — two things in short supply at hospitals
To obtain payment from a denied claim, a provider must investigate the claim, determine what they have to do to rectify the problem and resubmit the claim — a process that can take weeks — said Colleen Hall, the managing principal for Crowe’s healthcare consulting group, in a recent interview. This process creates “an aging accounts receivable situation” for the provider and delays them from receiving much-needed cash.
“There certainly are several for-profit insurers out there. I won’t name names, but I think that those for-profit entities are in direct conflict with the nonprofit hospitals. I don’t know what goes on in the for-profit payer side of things, but could there be actions that they’re deploying to delay payments? Potentially. There have certainly been denials that our clients, as providers, have to manage only to find were denied for no reason,” Hall declared.
In the first quarter of this year, about a third of the claims that providers submitted to commercial payers took more than three months to get paid, the report found.
It’s difficult for hospitals to gain steady financial footing when the payers that have the best reimbursement rates are holding onto a third of their claims payments for more than 90 days, Hall pointed out.
Photo: santima.studio, Getty Images
TORONTO, May 01, 2023 (GLOBE NEWSWIRE) — ODAIA, developers of MAPTUAL, an AI-powered commercial insights SaaS platform for pharmaceutical companies, today announced it raised an oversubscribed $25 Million Series B financing round, led by Threshold Ventures and co-led by Monograph Capital. Wittington Ventures also joined, with participation from existing investors Flint Capital, BDC Capital’s Women in Technology Venture Fund, StandUp Ventures and Graphite Ventures. Emily Melton, Managing Partner of Threshold Ventures and Charles Conn, co-founder and Partner of Monograph Ventures, will join ODAIA’s board. Megan Kelly, Principal of Threshold Ventures, will also join as a board observer. With its ability to provide near real-time and predictive perspective on the dynamic changes of the pharmaceutical marketplace, ODAIA’s proprietary platform MAPTUAL empowers leading life science brands to more efficiently get therapeutics, drugs and vaccines to the markets that need them with a modern, data-driven solution.
With several top 20 global pharmaceutical companies as customers, and having grown year-over-year annual recurring revenue (ARR) in 2022 by over 646%, ODAIA is transforming pharmaceutical marketing and commercialization with its lead product, MAPTUAL. MAPTUAL is a SaaS platform that leverages AI to streamline and automate the prospecting, qualifying and engagement of healthcare providers (HCP), a process that has largely been manual, labor intensive and time consuming. First, brands are onboarded quickly with data onboarding automation. The AI models then analyze data within hours to deliver actionable insights to reps, their managers and marketers. Insights include a robust understanding of the relevant providers and the patients they are treating, brand and market forecasts, target curation and prioritization for call planning, and an understanding of the most effective channels to reach those targets. No other platform puts so much information in front of pharma commercial teams so they can make robust data-driven decisions with near-real-time data and insights.
“ODAIA’s ability to constantly ingest and update a broad mix of life sciences data and turn it into comprehensive insights in near-real-time turns pharmaceutical sales from reactive to proactive,” said Emily Melton, Managing Partner at Threshold Ventures. “We’re thrilled to lead their Series B financing. ODAIA helps get life changing drugs into the hands of those who need them faster and more efficiently.”
“ODAIA has built impressive AI solutions that provide the pharmaceutical industry with the resources needed for the modern age,” said Charles Conn, Partner at Monograph Ventures. “We’re confident that this latest round of funding will further empower their impressive team to quickly scale their offering, which will benefit those who rely on therapeutics for their health and wellbeing.”
MAPTUAL is engineered to take the guess-work out of Pharma’s current workflow by unifying commercial teams through digestible and actionable predictive insights. Its two products, MAPTUAL Field and MAPTUAL Sphere, are built on an easy to navigate platform that provides a near-real-time and predictive perspective on a brand and its market;
- MAPTUAL Field provides sales reps with a granular view of health care providers, allowing pharma sales reps to use robust segments, prescription data – both historical and predicted – to improve their pre-call planning and spend more time seeing customers rather than analyzing data.
- MAPTUAL Sphere enables sales managers to effectively coach their team by discussing territory brand and market dynamics and HCP channel preferences. Marketers are also able to understand the contribution of different channels, by HCP segment, on prescription trends to make better marketing strategy and execution decisions.
Using MAPTUAL Field and MAPTUAL Sphere together allows for tailored insights to be delivered to the right teams, while ensuring consistency in analytics and data sources, and ultimately leading to better and timely patient care.
“Even in a challenging funding environment, our valued investors clearly recognized the significant problem we’re solving for the pharmaceutical industry,” said Philip Poulidis, CEO and Co-Founder of ODAIA. “With these funds, we’ll continue to evolve our product and build out our team to ensure we’re able to offer our existing and future life science brands the predictive tools needed for today’s market, and tomorrow’s. It’s our pleasure to welcome these investors to the ODAIA team.”
The 2020 global pandemic showcased the critical need to embrace new strategies in data, customer segmentation and brand experience across pharmaceuticals. Through its impressive predictive technology, ODAIA is unlocking smarter ways for leading life science companies to engage customers and lead to better patient care.
ABOUT ODAIA: ODAIA is the leading provider of automated commercial predictive insights trusted by global life sciences organizations. ODAIA leverages proprietary data-driven and AI-powered methods to identify distinct population subsets and their healthcare providers in the most efficient way possible. With ODAIA’s highly scalable and quick-to-deploy software-as-a-service platform, MAPTUAL, pharma sales reps can more efficiently engage with HCPs, sales managers can more effectively coach their teams, and marketers can gain a deep understanding of their market and develop campaigns that deliver strong business results. To learn more about ODAIA, visit www.odaia.ai or follow the company on LinkedIn and Twitter.
Media Contact
odaia@fischtankpr.com
FischTank PR
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- Kyowa Kirin now leads commercial efforts for CRYSVITA in 40 countries/regions around the world
- Company commits to keep patient needs at the forefront of commercial and education efforts
BEDMINSTER, N.J., April 27, 2023 /PRNewswire/ — Kyowa Kirin, Inc., an affiliate of Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a top 50 global specialty pharmaceutical company, today assumes primary commercial leadership for CRYSVITA® (burosumab-twza) injection in the United States and Canada from Ultragenyx Pharmaceutical, Inc., a transition planned for from the start of their decade-long collaboration. Initially discovered and developed by Kyowa Kirin, CRYSVITA is a first-in-class medicine used to treat adults and children 6 months of age and older with X-linked hypophosphatemia (XLH) and adults and children 2 years of age and older with fibroblast growth factor 23 (FGF23)–related hypophosphatemia in tumor-induced osteomalacia (TIO) when the tumor cannot be located or removed. The transition builds on the company’s existing commercial portfolio and commitment to address the needs of people living with rare diseases.
“Our collaboration with Ultragenyx has been a great success for children and adults living with XLH and TIO. Their contributions were instrumental in expediting late-stage trials, securing regulatory approval, and delivering treatment to thousands of patients,” said Steve Schaefer, President, Kyowa Kirin North America. “Kyowa Kirin intends to build on the successful launch and broad access that’s been established for CRYSVITA, as well as the learnings we have from working alongside XLH and TIO communities around the world, to bring more research, education, and support to patients in North America.”
To prepare for its new commercial leadership role in North America, Kyowa Kirin has engaged with community leaders and people living with XLH and TIO to gain perspective on their experiences and how best to support them. The company has distilled these conversations into a pledge that articulates how it will act to ensure patient voices are heard and reflected in the company’s decision-making going forward. To read the Pledge go here.
About the Partnership
Kyowa Kirin entered into a collaboration agreement with Ultragenyx in 2013 to hasten late-stage clinical studies and delivery of CRYSVITA to patients. Ultragenyx led Phase 3 studies and took responsibility for launching the medicine in the U.S., Canada, Latin America, and Turkey, while Kyowa Kirin leveraged its global footprint and capabilities to launch CRYSVITA across Europe, Asia, Australia, and the Middle East in addition to global manufacturing and distribution.
As part of the agreement, primary commercial responsibility for CRYSVITA in the U.S. and Canada would revert to Kyowa Kirin five years after first commercial use. During this time, the company experienced significant growth in North America, making significant investments in talent, technology, and infrastructure to support its rare disease business and services for patients, including the creation of Kyowa Kirin Cares, its comprehensive patient support program first launched to support the company’s oncology franchise. Starting May 1, 2023, all support services for CRYSVITA patients and caregivers in the U.S. will be provided through this program.
In addition to leading commercial efforts in Latin America and Turkey, Ultragenyx will continue to work with Kyowa Kirin for the next 12 months, providing support for some commercial activities in North America.
About XLH and TIO
X-linked hypophosphatemia is a rare, lifelong, genetic disease that can impact the bones and muscles in both children and adults. Tumor-induced osteomalacia is an extremely rare, difficult-to-diagnose disease caused by slow-growing tumors that occur throughout the body.
In XLH and TIO, the body doesn’t hold on to enough phosphorus, which is an essential mineral for bone health. This is due to the production of excess fibroblast growth factor 23 (FGF23), causing the body to release too much phosphorus through the urine. When phosphorus levels are too low (hypophosphatemia), it can cause the softening and weakening of growing bones in children (rickets) and mature bones in adults (osteomalacia).
In children, XLH typically appears as bowed legs or knock knees. Over time, bone weakening can also lead to bone abnormalities in the legs, delayed growth, and short stature. In adults, XLH may cause osteomalacia, fractures and pseudo-fractures, and hypophosphatemia. Patients with TIO may develop multiple bone abnormalities and can experience symptoms including severe hypophosphatemia, osteomalacia, and fractures. Symptoms are progressive and can lead to long-term disabilities, so it is vital that TIO be treated as soon as possible.
About CRYSVITA
CRYSVITA is a recombinant fully human monoclonal IgG1 antibody, discovered by Kyowa Kirin, which binds to and inhibits the biological activity of FGF23, the underlying cause of hypophosphatemia in XLH and TIO. By blocking FGF23, CRYSVITA helps to restore phosphorus reabsorption in the kidneys and increase the production of active vitamin D, which enhances intestinal absorption of phosphate and calcium.
U.S. CRYSVITA Indication
CRYSVITA is a prescription medicine used to treat adults and children 6 months of age and older with X-linked hypophosphatemia and adults and children 2 years of age and older with fibroblast growth factor 23 (FGF23)–related hypophosphatemia in tumor-induced osteomalacia when the tumor cannot be located or removed.
Important Safety Information
You should not take CRYSVITA if:
- You take an oral phosphate supplement and/or a specific form of vitamin D supplement (such as calcitriol, paricalcitol, doxercalciferol, calcifediol).
- Your phosphorus levels from a blood sample are within or above the normal range for age. You have kidney problems.
What is the most important information you should know about CRYSVITA?
- Some patients developed allergic reactions (e.g., rash and hives) while taking CRYSVITA. Your doctor will monitor you for symptoms of an allergic reaction while you are taking CRYSVITA.
- High levels of phosphorus in the blood have been reported in some patients taking CRYSVITA. This may be related to a risk of high calcium levels in the kidneys. Your doctor will collect blood samples to monitor your levels.
- Administration of CRYSVITA may result in reactions at the injection site, such as hives, reddening of the skin, rash, swelling, bruising, pain, severe itching of the skin, and collection of blood outside of a blood vessel (i.e., hematoma).
- If you are taking CRYSVITA for TIO, your doctor will have you stop your CRYSVITA treatment temporarily if you are undergoing treatment for your tumor (e.g., surgical removal of the tumor or radiation therapy).
What are the possible side effects of CRYSVITA?
- Adverse reactions that were seen in children with XLH are:
|
− Fever |
− Injection site reaction |
|
− Cough |
− Vomiting |
|
− Pain in arms and legs |
− Headache |
|
− Tooth abscess |
− Dental cavities |
|
− Diarrhea |
− Decreased vitamin D levels |
|
− Toothache |
− Constipation |
|
− Muscle pain |
− Rash |
|
− Dizziness |
− Nausea |
- Adverse reactions that were seen in adults with XLH are:
|
− Back pain |
− Headache |
|
− Tooth infection |
− Restless legs syndrome |
|
− Decreased vitamin D levels |
− Dizziness |
|
− Constipation |
− Muscle spasms |
|
− Phosphorus levels increased in the blood |
- Narrowing of the spaces within the spine is common in adults with XLH, and pressure on the spinal cord has been reported in adults taking CRYSVITA. It is not known if taking CRYSVITA worsens the narrowing of the spaces within the spine or the pressure on the spinal cord.
- Adverse reactions that were seen in adults with TIO are:
|
− Tooth abscess |
− Muscle spasms |
|
− Dizziness |
− Constipation |
|
− Injection site reaction |
− Rash |
|
− Headache |
Before taking CRYSVITA, tell your doctor about all of your medications (including supplements) and medical conditions, including if you:
- Are taking oral phosphate and/or active vitamin D (such as calcitriol, paricalcitol, doxercalciferol, calcifediol).
- Are pregnant, think you may be pregnant, or plan to become pregnant. There is not enough experience to know if CRYSVITA may harm your unborn baby. Report pregnancies to the Kyowa Kirin, Inc. Adverse Event reporting line at 1-844-768-3544.
- Are breastfeeding or plan to breastfeed. There is not enough experience to know if CRYSVITA passes into your breast milk. Talk with your doctor about the best way to feed your baby while you receive CRYSVITA.
While taking CRYSVITA, tell your doctor if you experience:
- An allergic reaction such as rash or hives
- A rash, swelling, bruising, or other reaction at the injection site
- New or worsening restless legs syndrome
These are not all the possible side effects of CRYSVITA. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Kyowa Kirin, Inc. at 1-844-768-3544.
For important risk and use information, please see the full Prescribing Information.
About Kyowa Kirin
Kyowa Kirin strives to create and deliver novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company with a more than 70-year heritage, we apply cutting-edge science including expertise in antibody research and engineering, to address the needs of patients and society across multiple therapeutic areas including Nephrology, Oncology, Immunology/Allergy and Neurology. Across our four regions – Japan, Asia Pacific, North America and EMEA/International – we focus on our purpose, to make people smile, and are united by our shared values of commitment to life, teamwork/Wa, innovation, and integrity. You can learn more about the Kyowa Kirin North America at: https://kkna.kyowakirin.com/.
SOURCE Kyowa Kirin
