Sage, Biogen complete rolling filing with FDA for depression therapy zuranolone
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Sage Therapeutics (NASDAQ:SAGE) and Biogen (NASDAQ:BIIB) completed 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) and postpartum depression (PPD).
The companies said that zuranolone is an investigational once-daily, 14-day oral short course treatment for adults with MDD and PPD.
The NDA was backed by data from the development programs LANDSCAPE and NEST. The LANDSCAPE program includes five studies of zuranolone in adults with MDD â MDD-201B, MOUNTAIN, SHORELINE, WATERFALL, and CORAL. Meanwhile, the NEST program includes two studies of zuranolone in adult women with PPD â ROBIN and SKYLARK.
Zuranolone received the FDA's fast track designation for MDD in 2017 and for PPD in 2022. It also got the breakthrough therapy designation in 2018.