Novo Nordisk’s Wegovy pill wins key EU backing

Rhea-AI Filing Summary

Novo Nordisk reports that the EMA’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending EU marketing authorisation for Wegovy® pill, a once-daily 25 mg oral semaglutide, for reducing excess body weight and maintaining long-term weight reduction in adults.

The opinion also supports including SELECT cardiovascular outcomes data in the label, showing Wegovy reduces the risk of major adverse cardiovascular events such as cardiovascular death, heart attack and stroke. In the phase 3b OASIS 4 trial, adherent patients achieved 16.6% mean weight loss, with about one in three reaching at least 20% weight loss.

The safety and tolerability profile matched previous semaglutide weight management trials, and semaglutide is backed by more than 50 million patient-years of real-world safety data. Novo Nordisk notes strong early U.S. demand for Wegovy pill and expects to bring the oral treatment to its first markets outside the U.S. in the second half of 2026, pending approvals.

Insights

Pharma & regulatory analyst

CHMP backing for Wegovy pill supports Novo Nordisk’s obesity and cardiometabolic growth strategy.

The positive CHMP opinion for Wegovy pill positions Novo Nordisk to add an oral GLP‑1 therapy for obesity in the EU, complementing its injectable Wegovy franchise. Oral dosing can broaden appeal, especially for patients reluctant to use injections, potentially deepening penetration of the obesity market.

The label’s inclusion of SELECT cardiovascular outcomes data, showing reduced risk of major adverse cardiovascular events, strengthens differentiation by linking weight loss to heart protection. Safety findings were consistent with prior semaglutide experience, which already spans more than 50 million patient‑years, lending further support to long-term use.

Management highlights that over 1 million Americans began using Wegovy pill within four months of its U.S. launch, indicating strong demand for an oral option. If EMA converts this opinion into marketing authorisation and national reimbursement follows, subsequent European launches, targeted for the second half of 2026, could add another growth leg to Novo Nordisk’s obesity and cardiometabolic portfolio.

Key Figures

Mean weight loss in OASIS 4: 16.6% mean weight loss High responders in OASIS 4: 1 in 3 patients Real-world semaglutide exposure: More than 50 million patient-years +4 more

7 metrics

Mean weight loss in OASIS 4 16.6% mean weight loss Adults with obesity or overweight adhering to oral semaglutide 25 mg treatment

High responders in OASIS 4 1 in 3 patients Participants achieving 20% or greater weight loss with Wegovy pill

Real-world semaglutide exposure More than 50 million patient-years Cumulative safety data supporting semaglutide use

OASIS programme enrolment Approximately 1,300 adults Global phase 3 OASIS trials in obesity and overweight

OASIS 4 trial size 307 adults Phase 3b efficacy and safety trial of oral semaglutide 25 mg vs placebo

Novo Nordisk employees About 67,900 people Global workforce across 80 countries

Early U.S. Wegovy pill users More than 1 million Americans Users within first four months following U.S. launch

Key Terms

glucagon-like peptide-1 (GLP-1) receptor agonist, major adverse cardiovascular events (MACE), OASIS trial programme, phase 3b trial, +2 more

6 terms

glucagon-like peptide-1 (GLP-1) receptor agonist medical

"Wegovy® pill is the first oral glucagon-like peptide-1 (GLP-1) receptor agonist therapy recommended for approval..."

A glucagon-like peptide-1 (GLP-1) receptor agonist is a type of medication that mimics a natural gut hormone to lower blood sugar and often reduce appetite, acting like a key that fits a specific cellular “lock” to change how the body handles glucose and hunger. Investors care because these drugs can drive large sales, affect healthcare costs and insurance coverage, and create regulatory and competitive risks or opportunities for drugmakers and related industries.

major adverse cardiovascular events (MACE) medical

"The positive opinion also includes SELECT data in the label, demonstrating that Wegovy® reduces the risk of major adverse cardiovascular events (MACE)..."

Major adverse cardiovascular events (MACE) is a medical shorthand for a group of the most serious heart- and blood-vessel related outcomes—typically heart attack, stroke, and cardiovascular death—used together as a single measure in studies and reports. Investors care because MACE rates summarize a therapy’s or device’s real-world safety and effectiveness for preventing life‑threatening events; like a single report card grade, they influence regulatory approval, prescribing, liability risk, and market adoption.

OASIS trial programme medical

"The recommendation is based on the OASIS trial programme and the SELECT2 trial."

phase 3b trial medical

"OASIS 4 was a 64-week efficacy and safety phase 3b trial of once-daily oral semaglutide 25 mg versus placebo..."

A phase 3b trial is an additional late-stage clinical study run after the main large-scale effectiveness trial but before or around regulatory approval, often to answer extra questions about dosing, safety in different groups, or real-world use. For investors, results can change the perceived chance of approval, the product’s final labeling, and the size of the market — like an extra road test that can reveal issues or advantages not seen in the main trial.

Market Abuse Regulation, Article 17 regulatory

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

marketing authorisation regulatory

"CHMP... has adopted a positive opinion, recommending marketing authorisation of Wegovy® pill..."

Marketing authorisation is the official permission from a regulatory authority to sell a medicine or medical product in a given market after its safety, quality and effectiveness have been reviewed. Think of it like a driver’s license for a drug: without it the product cannot be legally offered to patients, and with it a company can generate sales, face ongoing monitoring, and reduce regulatory risk—factors that directly affect investor value and revenue forecasts.

FAQ

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

What did Novo Nordisk (NVO) announce about its Wegovy pill in Europe?

Novo Nordisk announced that EMA’s CHMP issued a positive opinion recommending EU marketing authorisation for Wegovy pill, a once-daily 25 mg oral semaglutide, for long-term weight management in adults with obesity or overweight and at least one weight-related condition.

How effective was Novo Nordisk’s Wegovy pill in the OASIS 4 trial?

In OASIS 4, once-daily oral semaglutide 25 mg produced 16.6% mean weight loss among adults with obesity or overweight who adhered to treatment. Around one in three participants achieved at least 20% weight loss, with results similar to injectable Wegovy 2.4 mg in weight reduction.

Does Wegovy pill reduce cardiovascular risk according to Novo Nordisk’s data?

Yes. The proposed Wegovy label includes SELECT data showing reduced risk of major adverse cardiovascular events. These events include cardiovascular death, non-fatal heart attack and non-fatal stroke, supporting Wegovy as both a weight management and cardiometabolic risk reduction therapy in appropriate adult patients.

What safety profile does Novo Nordisk report for Wegovy pill?

Novo Nordisk states Wegovy pill reaffirmed the well-known safety and tolerability profile of semaglutide, comparable to prior weight management trials. Semaglutide is supported by more than 50 million patient-years of real-world safety data, and the Wegovy pill label includes no drug–drug restrictions with concomitant medications.

When could Wegovy pill launch in markets outside the United States?

Novo Nordisk expects to bring Wegovy pill to its first markets outside the United States in the second half of 2026, subject to regulatory approvals. The EU step depends on EMA converting the current positive CHMP opinion into formal marketing authorisation and subsequent country-level decisions.

How strong has early demand been for Novo Nordisk’s Wegovy pill in the U.S.?

Novo Nordisk reports that more than 1 million Americans began using Wegovy pill within the first four months after its U.S. launch. This rapid uptake indicates strong demand for an oral GLP-1 obesity treatment option alongside existing injectable formulations.

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

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Accepted by SEC EDGAR 05/22/2026 - 10:01 AM EDT 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 ☐

 

 

Wegovy® pill (oral semaglutide) recommended by CHMP for approval in the EU as the first oral GLP-1 representing the most efficacious oral obesity treatment in its class

· With a mean weight loss of 16.6%¹, Wegovy® pill demonstrates best-in-class weight-loss efficacy and is the first oral GLP-1 treatment recommended by CHMP for weight management in the EU.

· CHMP recommends Wegovy® pill for approval to reduce excess body weight and maintain long-term weight reduction. The recommendation also includes data from SELECT which demonstrates that Wegovy® reduces the risk of major adverse cardiovascular events (MACE)*, in the label.

· Wegovy® pill is the only oral GLP-1 treatment with no drug-drug restrictions in the label.

· Novo Nordisk plans to launch Wegovy® pill in select markets outside the US in the second half of 2026.

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® pill (once-daily oral semaglutide 25 mg) to reduce excess body weight and maintain long-term weight reduction. The positive opinion also includes SELECT data in the label, demonstrating that Wegovy® reduces the risk of major adverse cardiovascular events (MACE)*.

Wegovy® pill is the first oral glucagon-like peptide-1 (GLP-1) receptor agonist therapy recommended for approval by CHMP for weight management in the EU. The recommendation is based on the OASIS trial programme and the SELECT² trial. In the OASIS 4 trial, oral semaglutide 25 mg taken once daily demonstrated 16.6% mean weight loss when treatment was adhered to in adult participants with obesity or overweight with one or more comorbidities¹. The weight loss achieved with Wegovy® pill is similar to that of injectable Wegovy® 2.4 mg. Furthermore, one in three people experienced 20% or greater weight loss in the OASIS 4 trial1.

*Includes cardiovascular death, non-fatal heart attack (myocardial infarction) or non-fatal stroke.

¹Based on the trial product estimand from OASIS 4 trial, ie treatment effect if all people adhered to treatment.

²Supported with data from the STEP trial programme and the PIONEER PLUS trial.

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The well-known safety and tolerability profile of semaglutide was reaffirmed with Wegovy® pill in the OASIS 4 trial, which was comparable to previous semaglutide trials for weight management. Semaglutide is supported by more than 50 million patient-years of real-world safety data, and notably, the Wegovy® pill label includes no drug–drug restrictions with concomitant medications.

“We are encouraged by CHMP’s positive opinion for Wegovy® pill, bringing the most efficacious oral GLP-1 in its class one step closer to becoming the first approved oral treatment in its class for weight management in the EU”, said Mike Doustdar, president and CEO of Novo Nordisk. “The demand for effective and convenient obesity treatment is already evident in the U.S., where more than 1 million Americans began using Wegovy® pill within the first four months following launch. We look forward to bringing this innovative medicine to the first markets outside the US in the second half of 2026.”

About the OASIS trial programme

OASIS was a phase 3 clinical development programme with once-daily oral semaglutide 25 mg and 50 mg in obesity. The global clinical phase 3 programme consisted of four trials, enrolling approximately 1,300 adults with obesity or overweight with one or more comorbidities. OASIS 4 was a 64-week efficacy and safety phase 3b trial of once-daily oral semaglutide 25 mg versus placebo in 307 adults with obesity or overweight with one or more comorbidities.

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

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 33 / 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