05:14 PM EDT, 09/17/2025 (MT Newswires) -- Biogen (BIIB) said late Wednesday the European Commission granted marketing authorization for Zurzuvae, its once-daily oral therapy for postpartum depression in adults following childbirth.

The approval was based on results from the late-stage Skylark study, which showed Zurzuvae met its primary endpoint by significantly reducing depression scores on the Hamilton Rating Scale by day 15 compared to placebo. Secondary endpoints were also achieved, with improvements seen as early as day 3 and lasting through day 45.

Biogen said the 14-day treatment was generally well-tolerated, with the most common side effects including somnolence, dizziness and sedation.

Zurzuvae was cleared by the US Food and Drug Administration in 2023 and later scheduled as a class IV controlled substance by the Drug Enforcement Administration. Regulators in the U.K. approved the drug in August.

Shares of Biogen were up 1.3% in after-hours trading.