U.S. FDA Advisory Committee Votes To Recommend Approval For Brexanolone

A U.S. Food & Drug Administration (FDA) advisory committee recently voted to recommend approval for Brexanolone. If approved, Brexanolone would be the first drug specifically for individuals with postpartum depression.

The two committees involved—the FDA’s Psychopharmacologic Drugs Advisory committee and the Drug Safety and Risk Management Advisory committee—voted 18-0 in favor of the opinion that Sage Therapeutics demonstrated efficacy of brexanolone, 16-2 that the drug demonstrated safety, and 17-1 that the drug’s risks were outweighed by its benefits. For now, the main safety concern highlighted by the FDA revolves around the six . . .