FDA Updates: ALKS 3831 Wins Joint Panel Nod; Regeneron, Lilly Seek EUAs for Anti-COVID Antibodies

October 11, 2020

The PDUFA date for Alkermes' combination therapy is November 15, 2020.

Advisory panel OK for olanzapine/samidorphan. Alkermes’ novel therapy for schizophrenia and bipolar I disorder received a recommendation for approval Friday during a joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. Investigators have studied the combination as a way to safely deliver treatment for serious psychiatric disorders while mitigating the weight gain associated with olanzapine by adding samidorphan. In a series of votes, the group voted 16-1 that samidorphan meaningfully mitigates weight gain; 13-3 that the safety profile has been adequately characterized, and 11-6 that the labeling is sufficient to mitigate risks related to the opioid antagonist action of samidorphan.

“The favorable outcome of today’s joint advisory committee meeting represents an important milestone for the patients, clinicians and families who may benefit from new medicines for the treatment of schizophrenia and bipolar I disorder,” Craig Hopkinson, MD, chief medical officer and executive vice president of R&D at Alkermes, said in a statement. “The personal testimonies shared during today’s open public hearing reinforced the need for treatment approaches that consider patients’ overall mental and physical health.”

Alkermes’ proposed label would contraindicate the drug in patients who are opioid-dependent or chronically using opioids, and the plans a comprehensive education plan involving pharmacists. The company has previously presented results from the ENLIGHTEN-2 study, which showed a 57% higher mean weight gain among patients taking olanzapine alone than those taking the combination therapy after 24 weeks. At 52 weeks, patients taking ALKS 3831 had kept their weight stable. The scheduled target action date is November 15, 2020.

Regeneron, Lilly seek EUAs for antibodies to fight COVID-19. In the wake of President Donald Trump’s treatment with monoclonal antibodies for coronavirus disease 2019 (COVID-19) both Regeneron and Eli Lilly and Co. filed Wednesday with FDA for Emergency Use Authorization for their therapies to be made available to treat patients with COVID-19. Lilly, based in Indianapolis, is developing a product with Canadian biotech AbCellera Biologics, Inc., according to a statement released Wednesday; it is seeking an EUA for its therapy to be given to higher-risk patients with “mild to moderate” COVID-19. A phase 3 trial is studying the therapy as a preventive agent for residents and staff in long-term care facilities. Regeneron, whose therapy was given to Trump, also filed Wednesday for an EUA for REGN-CoV2, which combines 2 antibodies that work simultaneously and non-competitively to block the SARS-CoV-2, the virus that causes COVID-19.