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Biotechnology: Pharmaceutical Preparations
RegulatoryMay 22, 2026, 02:37 PM

Novo Nordisk: CHMP recommends EU approval for Wegovy 7.2 mg single-dose pen

AI Summary

Novo Nordisk announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending marketing authorisation for Wegovy® 7.2 mg (once-weekly injectable semaglutide 7.2 mg) in a single-dose pen for people living with obesity in the EU. The company anticipates launching the product in the EU in Q3 2026. Clinical trials showed Wegovy® 7.2 mg achieved an average weight loss of 20.7% in participants with obesity, with approximately one in three patients achieving 25% or greater weight loss. The single-dose pen is already approved and available in the US (as Wegovy® HD) and UK.

Key Highlights

  • CHMP recommended EU marketing authorisation for Wegovy® 7.2 mg in a single-dose pen.
  • Novo Nordisk expects to launch Wegovy® 7.2 mg single-dose pen in the EU in Q3 2026.
  • The STEP UP trial demonstrated 20.7% mean weight loss with semaglutide 7.2 mg.
  • Around one-third of patients in STEP UP achieved 25% or greater weight loss.
  • In the STEP UP T2D trial, semaglutide 7.2 mg showed 14.1% mean weight loss.
  • Wegovy® 7.2 mg in a single-dose pen is already available in the US (as Wegovy® HD) and UK.