Pharma Focus Asia

Biogen and Sage Therapeutics Announce FDA Accepts Filing of New Drug Application for Zuranolone

Monday, February 06, 2023

Biogen announced the U.S. Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for 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.

Zuranolone, a neuroactive steroid, has a novel mechanism of action as a positive allosteric modulator of GABA-A receptors. Zuranolone (SAGE-217/BIIB125) is a once-daily, 14-day, investigational drug in development for the treatment of major depressive disorder (MDD) and postpartum depression (PPD).

If approved, zuranolone, will become a meaningful treatment option which helps to address the serious unmet need faced by the diverse populations struggling with MDD and PPD and offers a new way for physicians to support patients.

In people with depression, it works by rapidly rebalancing dysregulated neuronal networks to help reset brain function. Zuranolone targets brain networks responsible for functions such as mood, arousal, behaviour, and cognition.

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.

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