Novo Nordisk Receives Positive CHMP Opinion for Wegovy® 7.2 mg Single-Dose Pen in the EU

25 May 2026 | Monday | News

Wegovy® 7.2 mg demonstrated up to 20.7% average weight loss in the STEP UP trial, with Novo Nordisk planning an EU launch in Q3 2026 following CHMP recommendation for approval of the once-weekly obesity treatment pen

  • Wegovy® 7.2 mg in a single-dose pen has now been recommended by CHMP for approval in the EU
  • Novo Nordisk expects to launch Wegovy® 7.2 mg in a single-dose pen in the EU in Q3 2026
  • In the STEP UP trial, Wegovy® 7.2 mg demonstrated an average weight loss of 20.7%1, and around one-third of patients achieved 25% or greater weight loss
  • Wegovy® 7.2 mg is already available in the U.S. for adults living with obesity under the brand name Wegovy® HD

Novo Nordisk announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorisation of Wegovy® 7.2 mg (once-weekly injectable semaglutide 7.2 mg) in a single-dose pen for people living with obesity.

Wegovy® 7.2 mg is already available in the EU for adults with obesity, dosed as three injections of 2.4 mg, and is based on results from the STEP UP trial programme. In the STEP UP trial, semaglutide 7.2 mg injected once weekly demonstrated 20.7%1 mean weight loss in participants with obesity, and approximately one in three people experienced 25% or greater weight loss. In the STEP UP T2D (type 2 diabetes) trial, in participants with obesity and type 2 diabetes, semaglutide 7.2 mg demonstrated a mean weight loss of 14.1%1. In both trials, the well-known safety and tolerability profile of semaglutide was reaffirmed with semaglutide 7.2 mg, which was comparable to previous trials with semaglutide for weight management.

“Since its launch in 2021, Wegovy® has transformed the lives of many people living with obesity and even more so with the approval earlier this year of Wegovy® 7.2 mg, which delivers around 21% weight loss,” said Mike Doustdar, president and CEO of Novo Nordisk. “With Wegovy® 7.2 mg now recommended for approval in the single-dose pen, people with obesity can reach their weight and health goals through a convenient, easy-to-use pen.”

Wegovy® 7.2 mg in the single-dose pen is already approved in the US and UK. In the US, Wegovy® 7.2 mg is launched under the brand name Wegovy® HD. Novo Nordisk expects to launch Wegovy® 7.2 mg in a single-dose pen in the EU in Q3 2026.

 

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