FDA panel backs Sage's postpartum depression candidate under REMS

A joint FDA panel voted 17-1 in favor of the benefit-risk profile for Zulresso brexanolone from Sage Therapeutics Inc. (NASDAQ:SAGE) to treat postpartum depression (PPD) when administered in certified facilities by qualified staff under a REMS. Sage said Zulresso could become the first drug specifically approved for the indication. The PDUFA date is Dec. 19.

FDA reviewers proposed implementing a REMS to address loss-of-consciousness events associated with Zulresso in briefing documents issued ahead of the joint advisory committee meeting. Sage also agreed that a REMS would be necessary and indicated it would gather data in a patient registry (see "FDA Reviewers: REMS Could Allay Safety Concerns for Sage's Brexanolone")...