Business
Biogen Receives European Commission Approval for ZURZUVAE® (zuranolone), the First and Only Treatment Approved for Women with Postpartum Depression in Europe
Postpartum depression is a leading cause of maternal mortality in Europe1-2, and is one of the most common medical conditions associated with pregnancy3-5; up
About this update from Biogen Inc.
[{"type":"text","content":"Postpartum depression is a leading cause of maternal mortality in Europe1-2, and is one of the most common medical conditions associated with pregnancy3-5; up to 20% of women experience postpartum depressive symptoms6-11The approval of this new therapeutic approach introduces an oral, 14-day treatment specifically indicated for PPDThe EC approval of ZURZUVAE is based on the SKYLARK study, which demonstrated rapid relief from depressive symptoms as early as day 3 and sustained through day 45 compared to placebo CAMBRIDGE, Mass., Sept. 17, 2025 (GLOBE NEWSWIRE) -- 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 ...