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Highlights

  • European Commission approves Biogen’s ZURZUVAE as first treatment for post-partum depression.
  • Authorization based on SKYLARK study showing symptom improvements by day 3.
  • PPD affects up to 20% of women in Europe after childbirth.

Biogen Inc. (Nasdaq: BIIB) announced that the European Commission (EC) has granted marketing authorization for ZURZUVAE® (zuranolone) for the treatment of post-partum depression (PPD) in adults following childbirth. The decision makes ZURZUVAE the first and only treatment specifically indicated for PPD in the European Union. The once-daily, oral therapy is administered over a 14-day course, representing a new therapeutic approach for women affected by this condition.

According to Biogen, ZURZUVAE has demonstrated efficacy in improving symptoms of PPD as early as day 3 of treatment. The company stated that this regulatory milestone underscores the need to address maternal mental health, as PPD remains underdiagnosed and undertreated across Europe.

PPD is one of the most common conditions linked with pregnancy, with symptoms including depressed mood, anxiety, impaired ability to bond with the newborn, and functional difficulties in daily activities. In more severe cases, mothers may experience feelings of worthlessness, guilt, and thoughts of self- or infant harm. If left untreated, the effects can extend beyond the postpartum period, potentially impacting maternal health and child development.

Data suggest that up to 20% of women in Europe with a recent pregnancy may experience PPD symptoms. Variations in clinical guidelines for screening and treatment across European countries contribute to underdiagnosis, leaving many cases untreated. Suicide during the perinatal period remains a leading cause of maternal mortality in the region.

The EC’s decision was based on results from the SKYLARK study, which evaluated the effectiveness and safety of ZURZUVAE. The trial met its primary endpoint, showing a significant mean reduction from baseline in the 17-item Hamilton Rating Scale for Depression (HAMD-17) at day 15 compared to placebo. Key secondary endpoints were also achieved, with reductions in depressive symptoms observed as early as day 3 and sustained through day 45.

ZURZUVAE was generally well-tolerated in clinical testing. The most frequently reported side effects (≥5% and greater than placebo) in patients receiving the 50 mg dosage were somnolence, dizziness, and sedation.

The approval by the European Commission paves the way for country-level engagement with health authorities to facilitate patient access. Biogen indicated it will work with medical professionals and regulators across Europe to address PPD treatment gaps through the introduction of ZURZUVAE.