Industrial-stage biotech Sage Therapeutics (NASDAQ:SAGE) announced on Monday that the company would submit a single new drug software (NDA) to the Food and drug administration for zuranolone, a candidate the organization developed with Biogen (BIIB) for two types of depression.
In April, the partners commenced the rolling submission of an NDA for zuranolone as a treatment method for significant depressive problem (MDD).
Previously, Sage (SAGE) announced it would comprehensive the NDA submission in H2 2022 for MDD and prepare to seek a different NDA submitting for the approval of zuranolone in postpartum despair (“PPD”) in early 2023, subject to completion of a late-phase demo.
As a substitute of two filings, Sage (SAGE) and Biogen (BIIB) have resolved to file a solitary NDA for the acceptance of zuranolone as a therapy for each MDD and PPD.
“The Business has knowledgeable the Food and drug administration of this update, and the Fda raised no objections and stated it looked ahead to continuing discussions with the Corporation,” Sage (SAGE) included in a regulatory submitting.
Ideas are underway to entire the submission less than priority review, the company reported, adding that the procedure will pace up the timeline for PPD indication. Sage (SAGE) expects the PDUFA goal action date for NDA to be in 3Q 2023.