European Medicine Agency Committee Recommends Zuranolone for Postpartum Depression

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NEWS BRIEF

This week, Biogen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recently adopted a positive opinion recommending marketing authorization for zuranolone (Zurzuvae) to treat postpartum depression (PPD).¹ If approved, this would be the first medication authorized in the European Union specifically to treat PPD. The European Commission will proceed to review the CHMP’s recommendation; a final decision is expected in the 3rd quarter of 2025.

Priya Singhal, MD, MPH, head of development at Biogen, said, “Zurzuvae represents a novel therapeutic approach for the targeted treatment of postpartum depression, with data demonstrating potential for symptom improvement as early as day 3 of a 14-day course. If approved, this represents a significant opportunity to advance the treatment of a serious condition that remains both underdiagnosed and undertreated.”

The CHMP recommended Zurzuvae based on the SKYLARK study, where the drug met its goal of significant reduction from baseline Hamilton Rating Scale for Depression total score at day 15 compared with placebo. The study also met its secondary goals with a significant reduction in depressive symptoms as early as day 3 of treatment and continued through day 45, compared with placebo. Adverse effects reported by treatment group patients greater than or equal to 5% and greater than placebo were somnolence, dizziness, and sedation.

PPD, left untreated, can lead to prolonged maternal morbidities and negative impacts on child development. In European countries, clinical guidelines for screening and management of depression during and after pregnancy can vary from country to country, so patients may go undiagnosed or untreated. An estimated 5% to 20% of pregnant women in Europe experience symptoms of PPD.² Additionally, suicide during the perinatal period is a leading cause of maternal mortality in Europe.

Zurzuvae is a neuroactive steroid GABA-A receptor positive allosteric modulator. Working in the GABA system allows this type of medication to regulate the major inhibitory signaling pathway of the brain and central nervous system, contributing to improved regulation of brain function.

Zurvuvae was approved by the US Food and Drug Administration in August 2023 and classified as a Class IV controlled substance by the Drug Enforcement Agency in October 2023.³ It was developed in collaboration between Biogen and Sage Therapeutics.

References

1. ZURZUVAE® (zuranolone) receives positive opinion from CHMP for the treatment of women with postpartum depression. News release. July 25, 2025. Accessed July 28, 2025. https://investors.biogen.com/news-releases/news-release-details/zurzuvaer-zuranolone-receives-positive-opinion-chmp-treatment

2. Wang Z, Liu J, Shuai H, et al. Mapping global prevalence of depression among postpartum women. Transl Psychiatry. 2021;11:543.

3. FDA approves first oral treatment for postpartum depression. August 4, 2023. Accessed July 28, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-postpartum-depression