FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Advisory Panel Recommends Post-Partum Depression Treatment

Nov. 30, 2018
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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.

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