Biogen's Zurzuvae Receives EMA Panel Recommendation for Postpartum Depression Treatment

Key Insights

• The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended marketing authorization for Biogen's ZURZUVAE (zuranolone) for treating postpartum depression in adults following childbirth.
• The recommendation is based on the SKYLARK study, where ZURZUVAE demonstrated significant reduction in depressive symptoms as early as Day 3 and sustained through Day 45 compared to placebo.
• If approved by the European Commission in Q3 2025, ZURZUVAE would become the first treatment specifically authorized within the European Union for postpartum depression.

Biogen Inc. has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for ZURZUVAE (zuranolone), marking a significant milestone toward the first EU-authorized treatment specifically indicated for postpartum depression in adults following childbirth.

The CHMP's recommendation, adopted on July 24, 2025, is based on results from the SKYLARK study, a multicentre, randomised, double-blind, placebo-controlled trial. In this pivotal study, ZURZUVAE met its primary endpoint by demonstrating a significant mean reduction from baseline in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score following two weeks of treatment.

Clinical Efficacy and Timeline

The study results showed particularly promising rapid-onset effects, with significant reduction in depressive symptoms observed as early as Day 3 and sustained through Day 45 compared to placebo. ZURZUVAE met all secondary endpoints in the trial, reinforcing its therapeutic potential for this patient population.

Mechanism of Action and Formulation

ZURZUVAE's active substance, zuranolone, is classified as a neuroactive steroid antidepressant (ATC code: N06AX31). The drug enhances the activity of the neurotransmitter gamma-aminobutyric acid (GABA) and is thought to exert antidepressant effects by enhancing GABAergic inhibition. The medication will be available as 20 mg, 25 mg, and 30 mg hard capsules.

Safety Profile

The most common side effects associated with ZURZUVAE include somnolence, dizziness, and sedation, according to the EMA assessment.

Regulatory Pathway Forward

The CHMP recommendation will now be reviewed by the European Commission for final marketing authorization in the European Union, with a decision expected in the third quarter of 2025. The applicant for this medicinal product is Biogen Netherlands B.V.

If approved, detailed recommendations for the use of ZURZUVAE will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages following the European Commission's marketing authorization decision.