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Alkermes’ Schizophrenia Drug Passes FDA Advisory Committee Hurdle

October 12, 2020

Via: BioSpace

Shares of Alkermes were up more than 12% in pre-market trading after the Ireland-based company announced late Friday that its schizophrenia drug was overwhelmingly supported by an advisory committee for the U.S. Food and Drug Administration (FDA).

A joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 16-1 in favor of the efficacy of ALKS 3831 (olanzapine/samidorphan) as a treatment for both schizophrenia and bipolar I disorder. The committee members also voted 13-3 in support of the investigational drug’s safety profile. There was one abstention in that vote.

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