By Fineline Cube 
US-based Biogen (NASDAQ: BIIB) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for Zurzuvae (zuranolone) for the treatment of postpartum depression (PPD) in adults. This recommendation paves the way for the European Commission (EC) review, with a final decision expected in the third quarter of 2025. If approved, Zurzuvae will be the first treatment authorized within the European Union specifically for PPD.
Drug Profile and Development
Zurzuvae, discovered by Sage, is a first-in-class neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM). It targets the GABA system, the major inhibitory signaling pathway of the brain and central nervous system, to regulate brain function. Biogen acquired global development and commercialization rights to the molecule, excluding Japan, Taiwan, and South Korea, through a November 2020 deal valued at USD 1.525 billion. This included an upfront payment of USD 875 million and a USD 650 million equity investment in Sage.
Clinical Trial Results
The CHMP’s recommendation is based on the SKYLARK Study, which demonstrated a significant mean reduction from baseline in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score at Day 15 compared to placebo. This study underscores Zurzuvae’s potential to address the significant unmet need for effective PPD treatments.
Regulatory Progress
Zurzuvae received FDA approval in 2023 as a once-daily, oral, 14-day treatment for PPD in adults. The positive CHMP opinion further strengthens its potential to become a pivotal treatment option for PPD in the European market.-Fineline Info & Tech