FDA advisory committees support ‘game-changing' drug brexanolone for postpartum depression
2 monthes ago - By Healio
By a 17-1 vote on Friday, the FDA's Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee said the benefits of Sage Therapeutics' brexanolone injection outweigh the risks for managing postpartum depression.
The committees also unanimously agreed that Sage Therapeutics presented “substantial evidence” to support its claim of brexanolone's effectiveness for postpartum depression and voted 16-2 that the company sufficiently characterized loss-of-consciousness events to allow brexanolone to be used safely.
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