[6-K] NOVO NORDISK A S Current Report (Foreign Issuer)
Rhea-AI Filing Summary
Novo Nordisk reports that the EU’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending marketing authorisation of a once-weekly Wegovy 7.2 mg single-dose pen for people living with obesity. Wegovy 7.2 mg is already available in the EU as three 2.4 mg injections.
The decision is supported by phase 3 STEP UP trials, where injectable semaglutide 7.2 mg produced a 20.7% mean weight loss in adults with obesity and 14.1% mean weight loss in adults with obesity and type 2 diabetes. In STEP UP, 31.2% of patients achieved at least 25% weight loss, and in STEP UP T2D, 21.3% achieved at least 20% weight loss.
The 7.2 mg single-dose pen is already approved in the US and UK, and Novo Nordisk expects to launch it in the EU in Q3 2026, adding a more convenient administration option to its existing obesity portfolio.
Positive
- None.
Negative
- None.
Insights
EU panel backing extends Wegovy’s obesity franchise with a higher-dose, single-pen option.
The positive CHMP opinion for Wegovy 7.2 mg in a single-dose pen strengthens Novo Nordisk’s obesity treatment lineup in Europe. The same total weekly dose is already available via three 2.4 mg injections, so this change mainly enhances convenience and adherence potential rather than expanding label scope.
Clinically, STEP UP data show 20.7% mean weight loss in adults with obesity and 14.1% in those with obesity and type 2 diabetes, with meaningful categorical loss rates. If the European Commission follows CHMP’s recommendation and the EU launch in Q3 2026 proceeds as planned, uptake will depend on real-world tolerance, supply, and how quickly physicians switch appropriate patients to the single-dose pen.
Key Figures
Key Terms
Committee for Medicinal Products for Human Use regulatory
efficacy estimand financial
treatment-regimen estimand financial
MASH medical
Market Abuse Regulation regulatory
semaglutide medical
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
________________
FORM 6-K
________________
REPORT OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
May 22, 2026
________________
NOVO NORDISK A/S
(Exact name of Registrant as specified in its charter)
Novo Allé 1
DK- 2880, Bagsvaerd
Denmark
(Address of principal executive offices)
________________
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F
| Form 20-F ☒ | Form 40-F ☐ |
CHMP recommends EU approval of Wegovy® 7.2 mg in a single-dose pen, providing up to 20.7% mean weight loss1
| · | 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.
1 Based on the efficacy estimand: treatment effect if all people adhered to treatment
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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.
| Mean weight loss at 72 weeks with semaglutide 7.2 mg in STEP UP trials | ||
| STEP UP | STEP UP T2D | |
| Efficacy estimand* | 20.7% | 14.1% |
| Treatment-regimen estimand** | 18.7% | 13.2% |
| Categorical weight loss*** |
31.2% of patients achieved ≥25% weight loss |
21.3% of patients achieved ≥20% weight loss |
* 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.
Publication of inside information pursuant to Market Abuse Regulation, Article 17.
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Contacts for further information:
| Novo Nordisk Media: | |
| Ambre James-Brown | Liz Skrbkova (US) |
| +45 3079 9289 | +1 609 917 0632 |
| globalmedia@novonordisk.com | usmediarelations@novonordisk.com |
| Novo Nordisk Investors: | |
| Michael Novod | Jacob Martin Wiborg Rode |
| +45 3075 6050 | +45 3075 5956 |
| nvno@novonordisk.com | jrde@novonordisk.com |
| Sina Meyer | Christoffer Sho Togo Tullin |
| +45 3079 6656 | +45 3079 1471 |
| azey@novonordisk.com | cftu@novonordisk.com |
| Alex Bruce | Mads Berner Bruun |
| +45 3444 2613 | +45 3075 2936 |
| axeu@novonordisk.com | mbbz@novonordisk.com |
| Frederik Taylor Pitter | |
| +1 609 613 0568 | |
| fptr@novonordisk.com |
Novo Nordisk A/S Investor Relations | Novo Allé 1 2880 Bagsværd Denmark | Telephone: +45 4444 8888 | www.novonordisk.com |
| Company announcement No 34/ 2026 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf of the undersigned, thereunto duly authorized.
| Date: May 22, 2026 |
NOVO NORDISK A/S
Maziar Mike Doustdar Chief Executive Officer |