Biogen, Sage to submit a single marketing application for depression candidate
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Commercial-stage biotech Sage Therapeutics (NASDAQ:SAGE) announced on Monday that the company would submit a single new drug application (NDA) to the FDA for zuranolone, a candidate the company developed with Biogen (BIIB) for two forms of depression.
In April, the partners began the rolling submission of an NDA for zuranolone as a treatment for major depressive disorder (MDD).
Previously, Sage (SAGE) announced it would complete the NDA submission in H2 2022 for MDD and plan to seek a separate NDA filing for the approval of zuranolone in postpartum depression (âPPDâ) in early 2023, subject to completion of a late-stage trial.
Instead of two filings, Sage (SAGE) and Biogen (BIIB) have decided to file a single NDA for the approval of zuranolone as a treatment for both MDD and PPD.
âThe Company has informed the FDA of this update, and the FDA raised no objections and stated it looked forward to continuing discussions with the Company,â Sage (SAGE) added in a regulatory filing.
Plans are underway to complete the submission under priority review, the company said, adding that the process will speed up the timeline for PPD indication. Sage (SAGE) expects the PDUFA target action date for NDA to be in 3Q 2023.