Sage, Biogen receive CRL for zuranolone in major depressive disorder

Sage Therapeutics (SAGE) and Biogen (BIIB) announced late Friday that the FDA issued a Complete Response Letter for the New Drug Application for zuranolone in the treatment of adults with major depressive disorder. The CRL stated that the application did not provide substantial evidence of effectiveness to support the approval of zuranolone for the treatment of MDD and that an additional study or studies will be needed, the companies said. Biogen and Sage “are reviewing the feedback and evaluating next steps.”