European Commission Approves 7.2 mg Once-Weekly Wegovy Dose for Adults With Obesity

The European Commission (EC) has approved a new 7.2 mg once-weekly maintenance dose of Wegovy (semaglutide injection) for adults with obesity. The regulatory action, based on a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued on December 12, 2025, provides an additional step-up option for patients requiring greater weight reduction after treatment with the 2.4 mg dose.¹

Under the updated authorization, clinicians in the EU may prescribe the 7.2 mg weekly dose, administered as three 2.4 mg injections administered consecutively during a single weekly dosing session. Novo Nordisk has also submitted an application for a dedicated 7.2 mg single-dose pen in the EU, which could become available later this year pending regulatory approval.

“This approval is another important step in helping people living with obesity reach very significant weight loss,” said Emil Kongshøj Larsen, executive vice president, International Operations, Novo Nordisk, in a press release. “The new dose gives healthcare professionals even more flexibility to tailor treatment and help people with obesity achieve their weight loss and health goals.”¹

Semaglutide, a GLP-1 receptor agonist, was initially approved by the FDA in June 2021 for chronic weight management in individuals with obesity or overweight and at least one weight-related condition, such as high blood pressure, type 2 diabetes, or high cholesterol, in addition to diet and increased exercise.²

Semaglutide has since approved by the FDA in both long-acting injectable (Wegovy and Ozempic) and daily oral tablet (Rybelsus) formulations. In March 2024, Wegovy was approved by the FDA to reduce the risk of major adverse cardiovascular events in adults with known heart disease and with obesity or overweight, in addition to a reduced calorie diet and increased physical activity.³

What evidence supported the EC approval?

The expanded dosing authorization is supported by findings from the Phase III STEP UP (NCT05646706) and STEP UP T2D clinical trials, which evaluated once-weekly semaglutide 7.2 mg in adults with obesity, without and with type 2 diabetes, respectively.⁴

• Results show the semaglutide 7.2 mg cohort achieved weight loss of 20.7% compared to 17.5% in the semaglutide 2.4 mg cohort and 2.4% in the placebo cohort.
• A total of 93.2% of patients in the semaglutide 7.2 mg cohort achieved weight loss of 5% or more compared to 92.5% in the semaglutide 2.4 mg cohort and 35.7% in the placebo cohort.
• Further, data show that when disregarding treatment adherence, the semaglutide 7.2 mg cohort achieved weight loss of 18.7% compared to 3.9% in the placebo cohort, with 90.7% of patients in the semaglutide 7.2 mg cohort achieving 5% or more weight loss compared to 36.8% in the placebo cohort.

Safety and Tolerability Profile of Semaglutide 7.2 mg

• In terms of safety, the most frequently reported adverse events (AEs) were gastrointestinal in nature, most of which were mild to moderate in severity. These AEs primarily occurred during dose escalation and faded as the trial progressed.
• A total of 3.3% of patients in the semaglutide 7.2 mg cohort discontinued treatment because of gastrointestinal AEs compared to 2.0% in the semaglutide 2.4 mg cohort and 0% in placebo cohort.

How does this approval expand Wegovy’s EU label?

Wegovy is indicated in the EU as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m²) with at least one weight-related comorbidity. It is also approved for adolescents aged 12 years and older with obesity and body weight above 60 kg.

The injectable formulation is currently available in 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg, and now 7.2 mg strengths across the EU. The higher maintenance dose enables eligible adults who have received 2.4 mg for at least four weeks to escalate directly to 7.2 mg if additional weight reduction is clinically warranted while maintaining muscle function.

The 7.2 mg dose is already approved and available in the UK. Regulatory applications are under review by the FDA and other global health authorities.

What are the clinical implications in Europe?

The EC decision provides European clinicians with greater flexibility in tailoring obesity treatment, particularly for patients requiring intensified pharmacologic intervention after initial dose optimization. With demonstrated incremental weight loss and preservation of lean mass parameters, the 7.2 mg dose adds to the therapeutic armamentarium amid growing demand for effective, scalable obesity management strategies across the EU.

References

1. Novo Nordisk A/S: The European Commission approves more effective dose of injectable Wegovy® for adults with obesity; clinical study showed people lost about 21% of their body weight on average. News release. Novo Nordisk. February 17, 2026. Accessed February 17, 2026. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html 

2. FDA Approves New Drug Treatment for Chronic Weight Management, First Since 2014. FDA. News release. June 4, 2021. Accessed February 17, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treatment-chronic-weight-management-first-2014

3. Wegovy® receives FDA approval for cardiovascular risk reduction in adults with known heart disease and overweight or obesity. Novo Nordisk. News release. March 8, 2024. Accessed February 17, 2026. https://www.novonordisk-us.com/media/news-archive/news-details.html?id=167031

4. A Research Study to See How Semaglutide Helps People With Excess Weight, Lose Weight (STEP UP). ClinicalTrials.gov. Updated December 11, 2025. Accessed February 17, 2026. https://clinicaltrials.gov/study/NCT05646706