FDA actions for the week ending August 21, 2020, include a hearing set for a drug that could limit weight gain often associated with treatment for serious mental illness.
Ofatumumab approved for relapsing MS. On Thursday, FDA approved a self-administered version of the biologic ofatumumab for relapsing forms of multiple sclerosis (MS), including relapsing-remitting disease, active secondary progressive disease, or clinically isolated syndrome. The treatment will be sold by as Kesimpta and be used once a month through an autoinjector pen. Approval is based on results from the phase 3 ASCLEPIOS I and II trials, which randomly assigned 946 patients to receive ofatumumab and 936 to receive teriflunomide. In these studies, annualized relapse rates (ARR) for patients with MS were reduced by 51% (ACLEPIOS I) and 58% (ACLEPIOS II). Novartis anticipates it will be available by September. The anti-CD20 monoclonal antibody is already approved to treat chronic lymphocytic leukemia.
Gilead’s filgotinib for RA rejected. FDA this week issued a Complete Response Letter (CRL) for filgotinib, Gilead Science’s investigational treatment for moderately to severely active rheumatoid arthritis (RA). Regulators said they needed additional data from the MANTA and MANTA-Ray studies to complete a review of the New Drug Application (NDA) and relayed concerns about the benefit-risk profile of the 200 mg dose of filgotinib. These studies are evaluating how the drug affects sperm, with results expected in the first half of 2021. “We are disappointed in this outcome and will evaluate the points raised in the CRL for discussion with the FDA,” Merdad Parsey, MD, PhD, chief medical officer, Gilead Sciences, said in a statement. “We continue to believe in the benefit/risk profile of filgotinib in RA, which has been demonstrated in the FINCH phase 3 clinical program.” Gilead is developing filgotinib with Galapagos NV; the drug has received a favorable review from the European Medicine Agency’s Committee for Medicinal Products for Human Use in both the 100 mg and 200 mg doses.
Advisory panel date set for ALKS 3831. Alkermes announced Friday evening that a joint meeting of the FDA Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will review its NDA for ALKS 3831, an investigational therapy for the treatment of adults with schizophrenia and bipolar I disorder, has been tentatively scheduled for October, 9, 2020. The date set for action under the Prescription Drug User Fee Act (PDUFA) is November 15, 2020. In a statement, the company highlighted anticipated areas of focus for the panel: (1) clinical meaningfulness of ALKS 3831's attenuation of olanzapine-associated weight gain, including the magnitude of weight effect and the impact of ALKS 3831 on laboratory-based metabolic parameters, and (2) “certain potential clinical risks” that relate to the interaction of ALKS 3831, which contains samidorphan, an opioid receptor antagonist, “and opioids in the intended patient populations.” ALKS 3831 is designed to address treatment needs for patients with schizophrenia and bipolar I disorder without the significant weight gain associated with olanzapine alone.
Vaccination Not a Risk Factor for Pediatric-Onset MS, Study Finds
December 16th 2024Previous studies have found no association between vaccination and MS in adults. To evaluate the association between vaccinations and pediatric-onset MS, researchers conducted a retrospective case-control study using data from the Bavarian Association of Statutory Health Insurance Physicians database.
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David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
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The Takeaway From Study of Midlife MS Patients: Don't Stop Disease-Modifying Therapy
Published: November 11th 2024 | Updated: November 11th 2024People with multiple sclerosis (MS) often stop taking disease-modifying therapy as they transition from relapsing-remitting MS to secondary progressive MS. This study shows that people who stop stop disease-modifying therapy have higher hospitalization rates and more visits to the emergency room.
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