SAGE - Sage Biogen begin rolling submission with FDA for zuranolone to treat depression

Sage Therapeutics (NASDAQ:SAGE) and Biogen (NASDAQ:BIIB) began a rolling submission of a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for approval of zuranolone to treat major depressive disorder (MDD). The companies said zuranolone is an investigational two-week, once-daily oral drug being developed for MDD and postpartum depression (PPD). The companies added that they have submitted the nonclinical module of the NDA to the FDA and plan to file the remaining components in H2 2022. Data from completed studies, LANDSCAPE and NEST, including data from an ongoing open-label study SHORELINE, of zuranolone in MDD, and information from the completed clinical pharmacology studies, will comprise the full submission package, the companies said in a May 2 release. Sage (SAGE) and Biogen  (BIIB) plan to submit an associated NDA filing for PPD in H1 2023. Zuranolone received the FDA's fast track designation for MDD in 2017 and the breakthrough therapy designation in 2018.

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Sage, Biogen begin rolling submission with FDA for zuranolone to treat depression