Sage Therapeutics Announces FDA Acceptance of NDA Filing and Grant of Priority Review for Brexanolone IV in the Treatment of Postpartum Depression

Sage Therapeutics (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for Sage’s lead product candidate, an intravenous formulation of brexanolone (SAGE-547) for the treatment of postpartum depression (PPD).

As quoted in the press release:

The NDA was granted Priority Review status and the FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of December 19, 2018. As expected for a new molecular entity with a new mechanism of action, the FDA is currently planning to hold an advisory committee meeting to discuss the brexanolone IV application.

If approved, brexanolone IV would be the first medication indicated for the treatment of PPD and would be Sage Therapeutics’ first commercial product. The FDA grants Priority Review to investigational therapies that, if approved, may offer significant improvements in the treatment, prevention or diagnosis of a serious condition. Brexanolone IV received Breakthrough Therapy Designation in September 2016, underscoring the significant unmet need in women with PPD.

Click here to read the full press release.