US biopharma Sage Therapeutics (Nasdaq: SAGE) looks all but certain to secure US approval for Zulresso (brexanolone) in postpartum depression after Food and Drug Administration (FDA) advisory committees supported its benefit-risk profile by 17 votes to one.
If approved, Zulresso would be the first medicine specifically indicated for postpartum depression.
The Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee based their joint recommendation on the safety and efficacy data from three placebo-controlled clinical studies.
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