European Commission Grants Approval for ZURZUVAE® (zuranolone) by Biogen, Marking it as the First and Only Treatment Authorized for Women Experiencing Postpartum Depression in Europe
Post-Partum Depression (PPD) is a common medical condition associated with pregnancy, affecting up to 20% of women with a recent pregnancy in Europe. This condition can lead to a range of symptoms, including depressed mood, anxiety, impaired ability to bond with the newborn, functional impairment of daily activities, feelings of guilt and worthlessness, doubts about motherhood, and thoughts of self- or infant harm.
In a significant step forward, the European Commission (EC) has granted marketing authorization for ZURZUVAE® (zuranolone), a novel therapeutic approach for treating PPD in adults. This approval makes ZURZUVAE the first and only treatment indicated for PPD in the European Union.
ZURZUVAE is a neuroactive steroid (NAS) and a GABA-A receptor positive allosteric modulator (PAM). It is designed to be a once-daily, oral, 14-day treatment. The EC's approval is based on the results of the SKYLARK study, which demonstrated rapid relief from depressive symptoms as early as day 3 and sustained through day 45 compared to placebo.
The organization that received the approval for ZURZUVAE is Biogen, a well-known biotechnology company. The U.S. Food and Drug Administration (FDA) approved ZURZUVAE in August 2023, and the Drug Enforcement Agency (DEA) scheduled it as a Class IV controlled substance in October 2023. Biogen Inc. also received regulatory approval for ZURZUVAE in the U.K. by the Medicines and Healthcare products Regulatory Agency (MHRA) in August 2025.
Death by suicide during the perinatal period is a leading cause of maternal mortality in Europe. The approval of ZURZUVAE is expected to provide a much-needed treatment option for women suffering from PPD, potentially saving lives and improving the mental health of new mothers across the continent.
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