Biogen has received European Commission approval for ZURZUVAE® (zuranolone), the first oral treatment specifically approved for postpartum depression (PPD) in adults in the European Union. This 14-day treatment offers rapid relief from depressive symptoms, with clinical trials showing significant improvement as early as day 3, sustained through day 45.
Postpartum depression affects up to 20% of new mothers in Europe, yet many cases remain undiagnosed and untreated. ZURZUVAE addresses this critical gap in maternal mental health by providing an effective, short-course oral therapy. The approval follows the positive results of the SKYLARK study, which demonstrated ZURZUVAE’s rapid and lasting symptom relief compared to placebo.
ZURZUVAE was generally well-tolerated, with the most common side effects being somnolence, dizziness, and sedation. The treatment course consists of once-daily dosing for two weeks, making it a convenient option for new mothers. Biogen highlights its commitment to expanding patient access to this important therapy across Europe.
ZURZUVAE was originally discovered by Sage Therapeutics, and Biogen has partnered to develop and commercialize the drug outside the U.S., where it received FDA approval in August 2023. The European Commission’s authorization underscores a significant advancement in the treatment of postpartum depression, offering hope to many women experiencing this challenging condition.
Frequently Asked Questions
What is ZURZUVAE approved for?
Treatment of postpartum depression in adult women following childbirth in the EU.
How long is the treatment?
The treatment is taken once daily for 14 days.
How quickly does it work?
Relief from symptoms was observed as early as day 3 in the SKYLARK study.
What are common side effects?
Somnolence, dizziness, and sedation.
Who developed ZURZUVAE?
Discovered by Sage Therapeutics and further developed and marketed by Biogen outside the U.S.
YOU MAY ALSO LIKE
