European Commission Approves Biogen’s ZURZUVAE® For Post-Partum Depression

Biogen Inc., today announced that the European Commission (EC) has granted marketing authorization for ZURZUVAE® (zuranolone) for the treatment of post-partum depression (PPD) in adults following childbirth. ZURZUVAE is the first and only treatment approved in the European Union for PPD, offering a novel, once-daily oral therapy taken over 14 days.

PPD is one of the most common complications of pregnancy, affecting up to 20% of women in Europe. Symptoms include depressed mood, anxiety, difficulty bonding with the newborn, impaired daily functioning, and, in severe cases, suicidal thoughts. Left untreated, PPD can persist beyond the postpartum period, impacting both maternal health and child development. Suicide during the perinatal period remains a leading cause of maternal mortality across Europe.

“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. 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,” said Priya Singhal, M.D., M.P.H., Head of Development at Biogen. 

The EC’s approval is based on results from the Phase 3 SKYLARK study, which met its primary endpoint of a significant reduction in depressive symptoms at day 15 as measured by the Hamilton Rating Scale for Depression (HAMD-17) compared to placebo. Improvements were observed as early as day 3 and were sustained through day 45. ZURZUVAE was generally well tolerated, with the most common side effects including somnolence, dizziness, and sedation.

This approval marks an important step in Biogen’s commitment to addressing serious mental health conditions, expanding treatment options for mothers across Europe, and supporting improved maternal and infant outcomes.