Novo Nordisk Wegovy HD 7.2 mg CHMP Positive Opinion (May 22): EMA Recommends EU Approval for High-Dose Injectable Semaglutide With 20.7% STEP UP Weight Loss, Q3 2026 EU Launch
Novo Nordisk announced May 22 that the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency adopted a positive opinion recommending marketing authorization of Wegovy 7.2 mg in a single-dose pen for adults living with obesity. Wegovy 7.2 mg is the high-dose once-weekly injectable formulation already available in the US as Wegovy HD. The STEP UP Phase 3 trial demonstrated 20.7% mean weight loss with the 7.2 mg dose, with approximately one in three participants experiencing ≥25% weight loss; in the STEP UP T2D trial, the same dose produced 14.1% mean weight loss in adults with obesity and type 2 diabetes. Novo expects to launch Wegovy 7.2 mg in the EU in Q3 2026. The CHMP opinion arrived the same day as the parallel positive recommendation for Wegovy pill (oral semaglutide 25 mg) — completing Novo's twin EU regulatory wins for the higher-dose injectable and the oral formulation simultaneously.