FDA accepts filing of SAGE 217 for major depressive disorder and postpartum depression
Biogen and Sage Therapeutics announced the FDA has accepted the filing of a New Drug Application (NDA) for SAGE 217 (zuranolone) in the treatment of major depressive disorder (MDD) and postpartum depression (PPD)
Zuranolone is an investigational drug being evaluated as a 14-day, rapid-acting, once-daily, oral treatment in adults with MDD and PPD. The application has been granted priority review and the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of August 5, 2023.
The zuranolone NDA includes data from the LANDSCAPE and NEST clinical development programs as well as a Phase II study of zuranolone completed by Shionogi in Japan in adults with MDD. The LANDSCAPE program includes five studies of zuranolone in adults with MDD (MDD-201B, MOUNTAIN, SHORELINE, WATERFALL, and CORAL). The NEST program includes two studies of zuranolone in adult women with PPD (ROBIN and SKYLARK). Zuranolone, a neuroactive steroid, has a novel mechanism of action as a positive allosteric modulator of GABA-A receptors. In people with depression, it is thought to work by rapidly rebalancing dysregulated neuronal networks to help reset brain function. Zuranolone targets brain networks responsible for functions such as mood, arousal, behavior, and cognition.
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