FDA Updates: Ofatumumab for MS, More Data Needed for Filgotinib in RA, Hearing Set for ALKS 3831

August 23, 2020

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.