Sage and Biogen’s Depression Drug Candidate Gets Priority Review

The FDA has granted priority review to a new drug application (NDA) by Sage Therapeutics and Biogen for zuranolone for the treatment of major depressive disorder (MDD) and postpartum depression (PPD).

A neuroactive steroid, zuranolone has a novel mechanism of action as a positive allosteric modulator of GABA-A receptors, the companies explained. The GABA system is the major inhibitory signaling pathway of the brain and central nervous system and contributes to regulating brain function.

The submitted data include the results of several studies that demonstrated “rapid and sustained effects and a well-tolerated safety profile” of zuranolone, the companies said.

The FDA has set a decision date of Aug. 5 to the investigational once-daily pill being evaluated as a 14-day, rapid-acting treatment in adults with MDD and PPD.