FDA Ad Com Oct. 9 for Alkermes schizophrenia, bipolar disorder med

The FDA’s Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet virtually on Friday, October 9, to review and discuss Alkermes plc’s (NASDAQ:ALKS) marketing application seeking approval of ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and adults with bipolar I disorder.

The FDA’s action date is November 15.

ALKS 3831 is a once-daily, oral atypical antipsychotic drug candidate designed to provide the efficacy of olanzapine while mitigating olanzapine-associated weight gain.

https://seekingalpha.com/news/3607804-fda-ad-com-october-9-for-alkermes-drug-for-schizophrenia-and-bipolar-disorder