Biogen gets European approval for postpartum depression treatment

Biogen Inc. (NASDAQ: BIIB) received European Commission marketing authorization for ZURZUVAE (zuranolone), an oral treatment for postpartum depression in adults. The 14-day treatment represents the first therapy specifically approved for postpartum depression in the European Union.

The approval was based on the SKYLARK study, which demonstrated that ZURZUVAE met its primary endpoint of significantly reducing depression symptoms compared to placebo at day 15, as measured by the Hamilton Rating Scale for Depression. The study showed symptom reduction as early as day 3, sustained through day 45.

Postpartum depression affects up to 20% of women with recent pregnancies in Europe, according to the company. The condition is among the most common medical complications associated with pregnancy and represents a leading cause of maternal mortality in Europe when left untreated.

ZURZUVAE is administered once daily for 14 days. The most frequently reported side effects occurring in at least 5% of patients and more than placebo were somnolence, dizziness and sedation.

The drug was previously approved by the U.S. Food and Drug Administration in August 2023 and by the UK's Medicines and Healthcare products Regulatory Agency in August 2025. The Drug Enforcement Agency classified it as a Schedule IV controlled substance.

ZURZUVAE was originally discovered by Sage Therapeutics, which Biogen partnered with in 2020 for development and commercialization. Biogen holds exclusive rights to develop and commercialize the drug outside the United States, excluding Japan, Taiwan and South Korea. Supernus Pharmaceuticals completed its acquisition of Sage Therapeutics in July 2025.

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