On Sept. 17, 2025, Biogen announced that the European Commission (EC) has granted marketing authorization for ZURZUVAE® (zuranolone) to treat post-partum depression (PPD) in adults following childbirth. ZURZUVAE is a once-daily, oral, 14-day treatment which represents a novel therapeutic approach, offering the first and only treatment indicated for PPD in the E.U.

PPD is one of the most common medical conditions associated with pregnancy. Symptoms of PPD may include depressed mood, anxiety, affected ability to bond with the newborn, functional impairment of daily activities, feelings of guilt and worthlessness, doubts about motherhood, and thoughts of self- or infant harm. Left untreated, PPD symptoms may persist beyond the postpartum period and can lead to prolonged maternal morbidities and repercussions on child development.

In Europe, up to 20% of women with a recent pregnancy experience symptoms of PPD. Because clinical guidelines for screening and management of depression during and after pregnancy vary across European countries, many cases may go undiagnosed and untreated. Death by suicide during the perinatal period is a leading cause of maternal mortality in Europe.

The EC’s approval of ZURZUVAE is based on the SKYLARK study that evaluated ZURZUVAE which met its primary end point, a significant mean reduction from baseline in the 17-item Hamilton Rating Scale for Depression (HAMD-17), a common measure of depression severity, at day 15 as compared to placebo. All key secondary endpoints were also met, with significant reduction in depressive symptoms being seen as early as day 3 and sustained through day 45 compared to placebo. ZURZUVAE was generally well-tolerated. The most frequently reported side effects ≥ 5% and greater than placebo in patients treated with ZURZUVAE 50 mg were somnolence, dizziness, and sedation.

The U.S. Food and Drug Administration (FDA) approved ZURZUVAE in August 2023 and the Drug Enforcement Agency (DEA) scheduled it as a Class IV controlled substance in October 2023. In August 2025, ZURZUVAE received regulatory approval in the U.K. by the Medicines and Healthcare products Regulatory Agency (MHRA).

ZURZUVAE^® is a once-daily, oral, 14-day medicine for treatment of postpartum depression (PPD) in adults. ZURZUVAE is a neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM). The GABA system is the major inhibitory signaling pathway of the central nervous system and contributes to regulating brain function. 

ZURZUVAE was discovered by Sage Therapeutics, Inc., and in 2020 Biogen and Sage Therapeutics entered into a collaboration to jointly develop and commercialize ZURZUVAE in the U.S. As part of the agreement, Biogen received exclusive rights to develop and commercialize ZURZUVAE outside of the U.S., excluding Japan, Taiwan and South Korea. In July 2025, Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN) completed its acquisition of Sage Therapeutics and is now the collaboration partner with whom Biogen is working in the U.S.