After granting priority review for the application, the FDA assigned a Prescription Drug User Fee Act (PDUFA) action date of 5 August 2023.
The drug is being evaluated as a 14-day, rapid-acting oral treatment once-a-day in adult subjects with MDD and PPD.
Biogen executive vice-president, Development head and Research and Global Safety and Regulatory Sciences interim head Priya Singhal said: “We see potential for zuranolone, if approved, to be a meaningful new option that can help address the serious unmet need faced by the diverse populations struggling with MDD and PPD.
“The FDA filing acceptance and granting of priority review are important milestones in the mission Biogen and our collaboration partner Sage share to advance the understanding and treatment of depression.”
Zuranolone is a neuroactive steroid and has a new mechanism of action as a positive allosteric GABA-A receptors modulator.
It is expected to work in depressed people by rapidly rebalancing dysregulated neuronal networks and helps reset brain function.
The drug acts on brain networks that are responsible for mood, arousal, behaviour, and cognition functions.
Sage Therapeutics chief medical officer Laura Gault said: “We are committed to advancing treatments that could help physicians and patients by addressing depression symptoms quickly. We believe zuranolone, if approved, could offer a new way for physicians to support patients.”