Alkermes' schizophrenia and bipolar drug set for virtual review

21 August 2020

Ireland-headquartered Alkermes (Nasdaq: ALKS) has announced that a tentative date has been set for a US Food and Drug Administration (FDA) advisory committee virtual review of the New Drug Application (NDA) for ALKS 3831 (olanzapine/samidorphan).

The Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will hold the virtual review on October 9, according to current plans.

ALKS 3831 is an investigational, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder.

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