Overview

• Biogen Netherlands B.V.’s Zurzuvae received a positive CHMP opinion on July 24 recommending EU marketing authorisation.
• Final authorisation now depends on European Commission approval and publication of the summary of product characteristics.
• Clinical trials showed that a 14-day course of zuranolone significantly reduces postpartum depressive symptoms within two weeks via GABAergic neuroactive steroid action.
• The drug will be available in 20 mg, 25 mg and 30 mg capsules and follows the FDA’s August 2023 nod as the first oral postpartum depression therapy.
• Patients may experience somnolence, dizziness and sedation, with detailed usage and safety guidelines to be outlined in the forthcoming official prescribing information.