On Aug. 4, 2023, Biogen and Sage Therapeutics announced that the U.S. Food and Drug Administration (FDA) had approved ZURZUVAE (zuranolone) 50 mg for adults with postpartum depression (PPD). ZURZUVAE was the first and only oral, once-daily, 14-day treatment that can provide rapid improvements in depressive symptoms for women with PPD.

The approval of ZURZUVAE to treat women with PPD was based on the NEST clinical development program, which included two studies in adult women with PPD (ROBIN and SKYLARK Studies). Both studies met their primary endpoint.