CHMP Endorses Novo Nordisk’s Single-Dose Wegovy 7.2 mg Pen

Novo Nordisk has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for Wegovy® 7.2 mg in a single‑dose injectable pen for adults with obesity. The recommendation advances the higher‑dose semaglutide formulation toward European Commission approval, anticipated in the third quarter of 2026, enabling a potential EU launch shortly thereafter.

Simplified Dosing

The new device delivers the full 7.2 mg weekly dose in a single injection, replacing the current EU regimen of three 2.4 mg injections. Wegovy® 7.2 mg is already approved in the United States, marketed as Wegovy® HD, and in the United Kingdom. Novo Nordisk CEO Mike Doustdar said the single‑dose pen could improve convenience and adherence for patients seeking sustained weight reduction.

STEP UP Programme Results

The CHMP opinion was supported by Phase 3 STEP UP trials. In the 72‑week STEP UP study (NCT05646706) of approx. 1,400 adults with obesity without diabetes, semaglutide 7.2 mg achieved 20.7% mean weight loss under the efficacy estimand, with one‑third losing ≥25% of body weight. In STEP UP T2D, enrolling ~500 adults with obesity and type 2 diabetes, mean weight loss was 14.1%. Safety remained consistent with the established semaglutide profile.

Expanding GLP‑1 Role

Beyond obesity, Wegovy® carries approvals for cardiovascular risk reduction and metabolic dysfunction‑associated steatohepatitis (MASH) in select regions, underscoring the broadening clinical role of GLP‑1 therapies across cardiometabolic disease.

 Reference

Novo Nordisk A/S: CHMP recommends EU approval of Wegovy® 7.2 mg in a single-dose pen, providing up to 20.7% mean weight loss 

Study Details | NCT05646706 | A Research Study to See How Semaglutide Helps People With Excess Weight, Lose Weight (STEP UP) | ClinicalTrials.gov