REMS prep pushes back Sage's Zulresso timeline

Sage Therapeutics Inc. (NASDAQ:SAGE) anticipates a June 2019 launch of postpartum depression candidate Zulresso brexanolone after FDA pushed back the PDUFA date three months to March 19. Sage has said Zulresso could become the first drug specifically approved for the indication.

The delay comes after Sage submitted a proposed REMS program with elements to ensure safe use (ETASU) at FDA's request. Sage said the agency did not ask for additional clinical data or information...