Biogen Receives European Commission Approval for ZURZUVAE® (zuranolone), the First and Only Treatment Approved for Women with Postpartum Depression in Europe
Biogen Inc. (Nasdaq: BIIB) 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.
“This approval is a major milestone in addressing a critical unmet need in maternal health for women in Europe, where postpartum depression is underdiagnosed and undertreated,” said Priya Singhal, M.D., M.P.H., Head of Development at Biogen. “ZURZUVAE is a 14-day treatment course which can improve the symptoms of PPD as early as day 3. This is a significant step forward from the current standards of care and our team is committed to engaging with the medical community and local authorities as we work to secure access for eligible European patients.”
PPD is one of the most common medical conditions associated with pregnancy.3-5 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.3 Left untreated, PPD symptoms may persist beyond the postpartum period and can lead to prolonged maternal morbidities and repercussions on child development.1, 12, 13
In Europe, up to 20% of women with a recent pregnancy experience symptoms of PPD.6-11 Because clinical guidelines for screening and management of depression during and after pregnancy vary across European countries, many cases may go undiagnosed and untreated.5 Death by suicide during the perinatal period is a leading cause of maternal mortality in Europe.1-2
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.
For detailed product information, please see the Summary of Product Characteristics on the European Medicines Agency website at www.ema.europa.eu.
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).
