This week, Biogen revealed that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending marketing authorization for zuranolone (brand name Zurzuvae) as a treatment for postpartum depression (PPD).
If ultimately approved, zuranolone would make history as the first medication specifically authorized in the European Union to address PPD.
The European Commission will now review the CHMP’s recommendation, with a final decision anticipated in the third quarter of 2025. This milestone comes as a significant development in addressing a condition that affects a substantial portion of new mothers across Europe.
Priya Singhal, MD, MPH, head of development at Biogen, emphasized the drug’s potential: “Zurzuvae offers a novel therapeutic approach for targeting postpartum depression, with data showing symptom improvement as early as day 3 of a 14-day treatment course. If approved, it would mark a crucial step forward in treating a serious condition that remains widely underdiagnosed and undertreated.”
The CHMP’s favorable stance is rooted in findings from the SKYLARK study, which demonstrated that zuranolone met its primary goal: a statistically significant reduction in depressive symptoms, as measured by the Hamilton Rating Scale for Depression total score, by day 15 compared to a placebo.
The study also achieved key secondary objectives, with notable symptom relief observed as early as day 3—effects that persisted through day 45. Adverse effects reported more frequently in the treatment group (at a rate of 5% or higher, compared to placebo) included somnolence, dizziness, and sedation.
Postpartum depression, when left untreated, can lead to long-term health issues for mothers and negative impacts on child development. In Europe, clinical guidelines for screening and managing depression during and after pregnancy vary by country, contributing to high rates of undiagnosed or untreated cases.
Estimates suggest that 5% to 20% of pregnant women in Europe experience PPD symptoms, and suicide during the perinatal period ranks among the leading causes of maternal mortality in the region.
Zurzuvae belongs to a class of drugs known as neuroactive steroid GABA-A receptor positive allosteric modulators. By targeting the GABA system, it regulates the brain’s major inhibitory signaling pathway, helping to restore balanced brain function— a mechanism thought to underpin its effectiveness in treating PPD.
Notably, zuranolone has already gained traction in the United States: the US Food and Drug Administration approved it in August 2023, and the Drug Enforcement Agency classified it as a Class IV controlled substance two months later. The medication was developed through a collaboration between Biogen and Sage Therapeutics.
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