SAGE Therapeutics (SAGE), Biogen (BIIB) ZURZUVAETM approved in PPD, receives CRL for MDD

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Go back to SAGE Therapeutics (SAGE), Biogen (BIIB) ZURZUVAETM approved in PPD, receives CRL for MDD

FDA Approves ZURZUVAE™ (zuranolone), the First and Only Oral Treatment Approved for Women with Postpartum Depression, and Issues a Complete Response Letter for Major Depressive Disorder

August 4, 2023 10:42 PM EDT

Postpartum depression (PPD) approval based on results from two Phase 3 clinical trials; in the SKYLARK Study treatment with ZURZUVAE rapidly improved symptoms of PPD at Day 15 and as early as Day 3 with sustained effect to Day 45

Mental health conditions are the leading cause of maternal mortality1 with PPD among the most common complications during and after pregnancy2

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Sage Therapeutics, Inc. (Nasdaq: SAGE) and... More