• 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

Bagsværd, Denmark, 22 May 2026 – Novo Nordisk today 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.

About the STEP UP trials
The STEP UP and STEP UP T2D phase 3 trials investigated the efficacy and safety of injectable semaglutide 7.2 mg in people with obesity without or with type 2 diabetes.

The 72-week STEP UP trial evaluated the efficacy and safety of injectable semaglutide 7.2 mg compared to semaglutide 2.4 mg and placebo as an adjunct to lifestyle intervention. The trial included approximately 1,400 adults with obesity. The 72-week STEP UP T2D trial evaluated the efficacy and safety of injectable semaglutide 7.2 mg compared to placebo in approximately 500 adults with obesity and type 2 diabetes.

^* Treatment effect if all people adhered to treatment, ^** Treatment effect regardless of treatment adherence,
^*** Observed proportions based on in-trial period

About Wegovy^®
Once-weekly Wegovy^® injection (2.4 mg and 7.2 mg) is approved by the FDA, EMA and other regulatory authorities worldwide. Wegovy^® is approved as once-daily Wegovy^® pill (semaglutide 25 mg) by the FDA. Wegovy^® pill is currently pending marketing approval from the EMA and other regulatory authorities.

Wegovy^® is indicated to reduce excess body weight and maintain weight reduction long term in adults with obesity or overweight and in the presence of at least one weight-related comorbid condition, and approved by the FDA to reduce the risk of major adverse cardiovascular events, such as death, heart attack or stroke in adults with known heart disease and either obesity or overweight. Furthermore, Wegovy^® injection is indicated to reduce excess body weight and maintain long-term weight reduction in paediatric patients aged 12 years and older. It is approved by the FDA for the treatment of MASH in adults with moderate to advanced liver scarring (fibrosis), but not in those with cirrhosis of the liver.

About Novo Nordisk
Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 67,900 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube.

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Contacts for further information

Company announcement No 34 / 2026

¹ Based on the efficacy estimand: treatment effect if all people adhered to treatment