ZURZUVAE® (zuranolone) Receives Positive Opinion from CHMP for the Treatment of Women with Postpartum Depression

Core Viewpoint - Biogen Inc. announced a positive opinion from the CHMP recommending marketing authorization for ZURZUVAE (zuranolone) for treating postpartum depression (PPD) in adults, which could be the first EU-approved treatment specifically for PPD if approved by the European Commission [1][5]. Company Summary - Biogen is a leading biotechnology company founded in 1978, focusing on innovative science to develop new medicines and create shareholder value [8]. - The company collaborates with Sage Therapeutics for the development and commercialization of ZURZUVAE, holding exclusive rights outside the U.S. [7]. Product Summary - ZURZUVAE is a once-daily, oral, 14-day treatment for PPD, approved by the FDA in 2023, and is a neuroactive steroid that modulates GABA-A receptors [6]. - The treatment has shown potential for symptom improvement as early as day three of a 14-day course, with significant reductions in depressive symptoms observed [2][4]. Market Opportunity - An estimated 5-20% of women experience PPD symptoms in Europe, with many cases going undiagnosed due to varying clinical guidelines [3]. - The recommendation for ZURZUVAE is based on the SKYLARK Study, which demonstrated significant efficacy in reducing depression severity compared to placebo [4].