Biogen’s ZURZUVAE Approved in Europe as First Treatment for Postpartum Depression
Biogen Inc. announced that the European Commission (EC) has granted marketing authorization for ZURZUVAE (zuranolone) as a treatment for postpartum depression (PPD) in adults following childbirth. The decision marks a significant milestone, making ZURZUVAE the first and only approved treatment for PPD in the European Union.
ZURZUVAE is a once-daily, oral, 14-day medication that introduces a novel therapeutic approach to maternal mental health. The approval follows years of limited treatment options for postpartum depression, a condition that affects up to 20% of women after pregnancy in Europe and is often underdiagnosed and undertreated.
“This approval is a major milestone in addressing a critical unmet need in maternal health for women in Europe,” said Dr. Priya Singhal, Head of Development at Biogen. “ZURZUVAE can improve symptoms of PPD as early as day three, representing a significant step forward from current standards of care.”
A Widespread and Underrecognized Condition
Postpartum depression is among the most common complications of pregnancy and can manifest through a range of symptoms, including persistent sadness, anxiety, impaired bonding with the newborn, and thoughts of self-harm. If left untreated, PPD can have long-lasting consequences for both mother and child, including increased risk of maternal morbidity and developmental challenges in the child.
Current treatment guidelines and screening practices for PPD vary widely across European countries, contributing to inconsistent diagnosis and care. Suicide during the perinatal period remains one of the leading causes of maternal mortality in Europe.
Backed by SKYLARK Clinical Trial
The EC’s decision was based on data from the SKYLARK study, which demonstrated ZURZUVAE’s effectiveness in significantly reducing symptoms of depression as measured by the 17-item Hamilton Rating Scale for Depression (HAMD-17). Improvements were observed as early as day 3, with sustained effects through day 45 compared to placebo. The drug was generally well tolerated; the most common side effects included somnolence, dizziness, and sedation.
Global Regulatory Milestones
ZURZUVAE was previously approved by the U.S. Food and Drug Administration (FDA) in August 2023 and was classified as a Schedule IV controlled substance by the Drug Enforcement Agency (DEA) shortly afterward. In August 2025, the treatment also received regulatory approval in the United Kingdom from the Medicines and Healthcare products Regulatory Agency (MHRA).
With this latest approval from the European Commission, Biogen plans to work closely with healthcare providers and regulatory bodies across Europe to ensure patient access to the groundbreaking treatment.