A joint FDA advisory committee voted in favor of the effectiveness, safety and risk-benefit profile of Sage Therapeutics’ NDA for the treatment of post-partum depression.
The Psychopharmacologic Drugs Advisory and Drug Safety and Risk Management Advisory committees voted 18-0 on the effectiveness of brexanolone 5 mg/mL intravenous injection.
“The evidence is pretty clear that it works” within 60 hours, said temporary voting member Gregory Burger, a medication safety coordinator in Lecompton, Kansas.
The committee voted 16-2 in favor of the NDA’s safety and 17-1 in favor of its risk-benefit profile. The FDA has a target decision date of Dec. 19 for the NDA.