Priority review for Biogen and Sage's depression drug
US pairing Biogen (Nasdaq: BIIB) and Sage Therapeutics (Nasdaq: SAGE) have announced that the US Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for zuranolone in the treatment of major depressive disorder (MDD) and postpartum depression (PPD).
Zuranolone is an investigational drug being evaluated as a 14-day, rapid-acting, once-daily, oral treatment in adults with MDD and PPD.
The application has been granted priority review and the FDA has assigned a Prescription Drug User Fee Act action date of August 5, 2023.
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