Novo Nordisk gets CHMP backing for Wegovy 7.2 mg pen

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.

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.

Insights

Pharmaceutical and regulatory analyst

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

Mean weight loss (obesity, efficacy estimand): 20.7% Mean weight loss (T2D, efficacy estimand): 14.1% Mean weight loss (obesity, treatment-regimen): 18.7% +5 more

8 metrics

Mean weight loss (obesity, efficacy estimand) 20.7% STEP UP trial, semaglutide 7.2 mg once weekly at 72 weeks

Mean weight loss (T2D, efficacy estimand) 14.1% STEP UP T2D trial, semaglutide 7.2 mg once weekly at 72 weeks

Mean weight loss (obesity, treatment-regimen) 18.7% STEP UP trial, regardless of adherence at 72 weeks

Mean weight loss (T2D, treatment-regimen) 13.2% STEP UP T2D trial, regardless of adherence at 72 weeks

High categorical weight loss (obesity) 31.2% Patients achieving ≥25% weight loss in STEP UP

High categorical weight loss (T2D) 21.3% Patients achieving ≥20% weight loss in STEP UP T2D

Trial duration 72 weeks STEP UP and STEP UP T2D phase 3 trials

Trial enrollment ≈1,400 and ≈500 adults STEP UP and STEP UP T2D adults with obesity, with/without type 2 diabetes

Key Terms

Committee for Medicinal Products for Human Use, efficacy estimand, treatment-regimen estimand, MASH, +2 more

6 terms

Committee for Medicinal Products for Human Use regulatory

"the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency"

The Committee for Medicinal Products for Human Use is the expert scientific panel within the European medicines regulator that assesses whether medicines for people are safe, effective and of acceptable quality, and issues formal opinions used in the drug-approval process. Its assessments act like a gatekeeper or safety inspector for entering the European market, so the committee’s opinion can materially affect a drug’s commercial prospects, regulatory risk and a company’s stock valuation.

efficacy estimand financial

"Efficacy estimand* | 20.7% | 14.1%"

An efficacy estimand is the precise definition of the treatment effect a clinical trial aims to measure — who is being measured, what outcome counts, and how events like missed doses or additional medicines are handled. Think of it as the exact recipe and rules for measuring a cake’s taste so different tasters and interruptions don’t muddy the result. Investors care because the estimand determines how convincing and comparable trial results are, which directly affects regulatory decisions, market expectations, and valuation risk.

treatment-regimen estimand financial

"Treatment-regimen estimand** | 18.7% | 13.2%"

MASH medical

"It is approved by the FDA for the treatment of MASH in adults with moderate to advanced liver scarring"

Market Abuse Regulation regulatory

"Publication of inside information pursuant to Market Abuse Regulation, Article 17."

Market abuse regulation consists of laws and rules designed to prevent dishonest or manipulative practices in financial markets. It aims to ensure fair and transparent trading, so investors can trust that markets operate honestly, much like rules that keep a game fair. By reducing unfair advantages, it helps protect investor confidence and promotes healthy, efficient markets.

semaglutide medical

"once-weekly injectable semaglutide 7.2 mg in a single-dose pen for people living with obesity"

Semaglutide is a medication originally developed to help manage blood sugar levels in people with diabetes, but it also promotes weight loss. It works by mimicking a natural hormone that helps control appetite and insulin release. For investors, its potential to influence healthcare and weight management markets makes it a significant product in the pharmaceutical industry.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Novo Nordisk (NVO) announce about Wegovy 7.2 mg in Europe?

Novo Nordisk announced that the EU’s CHMP issued a positive opinion recommending marketing authorisation for once-weekly Wegovy 7.2 mg in a single-dose pen for obesity. The product is already available in the EU as three weekly 2.4 mg injections delivering the same dose.

How effective was Wegovy 7.2 mg in the STEP UP obesity trials for Novo Nordisk (NVO)?

In the STEP UP trial, once-weekly semaglutide 7.2 mg produced 20.7% mean weight loss using the efficacy estimand. Around 31.2% of patients achieved at least 25% weight loss over 72 weeks, on top of lifestyle interventions, demonstrating substantial body-weight reduction in adults with obesity.

How did Wegovy 7.2 mg perform in people with obesity and type 2 diabetes in Novo Nordisk’s (NVO) STEP UP T2D trial?

In STEP UP T2D, once-weekly semaglutide 7.2 mg achieved 14.1% mean weight loss using the efficacy estimand in adults with obesity and type 2 diabetes. Additionally, 21.3% of participants reached at least 20% weight loss over 72 weeks, while maintaining a safety profile consistent with prior semaglutide studies.

When does Novo Nordisk (NVO) expect to launch the Wegovy 7.2 mg single-dose pen in the EU?

Novo Nordisk expects to launch the Wegovy 7.2 mg single-dose pen in the European Union in Q3 2026, following the positive CHMP opinion. Final marketing authorisation depends on the European Commission’s decision, and the pen aims to offer a more convenient weekly obesity treatment option.

Where else is Novo Nordisk’s Wegovy 7.2 mg single-dose pen already approved?

The Wegovy 7.2 mg single-dose pen is already approved in the United States and the United Kingdom. In the US, the 7.2 mg strength is marketed under the brand name Wegovy HD, complementing Novo Nordisk’s broader Wegovy injectable and oral obesity treatment portfolio.

What other conditions is Wegovy approved to treat according to Novo Nordisk (NVO)?

Wegovy injection is approved to reduce excess body weight long term in adults and certain adolescents with obesity or overweight and comorbidities. It is FDA-approved to lower major cardiovascular event risk in adults with heart disease and obesity, and to treat MASH with moderate to advanced liver fibrosis in adults without cirrhosis.

AI-generated analysis. How Rhea-AI works. Not financial advice.

Form 6-K: How Foreign Companies Report to the SEC →

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Accepted by SEC EDGAR 05/22/2026 - 02:32 PM Learn about SEC filing dates

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 CVR no: 24 25 67 90
			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