SAGE Therapeutics (SAGE), Biogen (BIIB) to Submit NDA for Zuranolone to FDA in Second Half of 2022 with Rolling Submission Expected to Start in Early 2022

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Go back to SAGE Therapeutics (SAGE), Biogen (BIIB) to Submit NDA for Zuranolone to FDA in Second Half of 2022 with Rolling Submission Expected to Start in Early 2022

Sage Therapeutics and Biogen Announce Plans to Submit a New Drug Application (NDA) for Zuranolone to the U.S. Food & Drug Administration in the Second Half of 2022 with Rolling Submission Expected

October 19, 2021 6:30 AM EDT

Following the pre-NDA meeting, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD

The planned initial submission package will be for the treatment of MDD with an anticipated PPD filing thereafter

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) today announced their plan to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for... More