European Commission Approves 7.2 mg Wegovy Dose for Adults with Obesity

The European Commission has authorized a new 7.2 mg once-weekly dose of Wegovy (semaglutide) for adults with obesity across all 27 EU member states, following positive opinion from the EMA's scientific committee in December 2025.

The European Commission approved a new 7.2 mg once-weekly dose of Wegovy (semaglutide) for adults with obesity on February 17, 2026, covering all 27 EU member states. The approval follows a positive opinion from the European Medicines Agency's scientific committee (CHMP) in December 2025.

The higher dose adds to previous injectable Wegovy doses of 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg. The 7.2 mg dose is administered as three 2.4 mg injections in one sitting. A separate approval process is under way for a single 7.2 mg injection pen, with potential market launch later in 2026 pending approval.

Data from the 1,407-participant STEP UP study, which lasted roughly 18 months, showed participants on the 7.2 mg dose combined with lifestyle changes lost an average of 21% of their body weight over 72 weeks, compared with just 2% for those on placebo. Nearly one in three participants lost 25% or more of their body weight. This represents an improvement over the 15% to 17% range previously confirmed with the 2.4 mg dose of Wegovy, and data from around 2,000 patients across two Phase III trials demonstrated that the 7.2 mg dose led to 21% body weight loss.

The majority of the weight lost—84%—came from fat, with muscle function preserved. The most common side effects were mild to moderate and transient, including nausea, diarrhea, vomiting (24.8%), and dysaesthesia (22.9%).

The executive vice president of international operations stated that the approval is another important step in helping people living with obesity reach very significant weight loss, and that the new dose gives healthcare professionals even more flexibility to tailor treatment and help people with obesity achieve their weight loss and health goals.

In the United States, an application was submitted to the FDA in November 2025 for approval of the 7.2 mg Wegovy product. The review is under way using a priority review voucher that significantly shortens the review period, specifically the FDA's Commissioner's National Priority Voucher (CNPV) programme, and approval could come as early as February 2026. Wegovy 7.2 mg was approved in the UK in January 2026.

Compared with the 21% weight-loss rate over 72 weeks for the already marketed 15 mg dose of Mounjaro (tirzepatide), the gap has narrowed significantly. Unlike semaglutide, which acts only on GLP-1 receptors, tirzepatide simultaneously stimulates GLP-1 and gastric inhibitory polypeptide (GIP) receptors, yielding greater weight-loss effects in clinical trials. Mounjaro's highest approved dose in Europe is 15 mg.

Global revenue for Wegovy reached $12.5 billion in 2025. Mounjaro generated approximately $23 billion in global revenue in 2025, while Zepbound—the US brand name for obesity—contributed $13.5 billion. The obesity market across the seven major markets (the US, France, Germany, Italy, Spain, the UK, and Japan) is forecast to reach $173.5 billion by 2031.

In the United States in January 2026, an oral, once-daily version of Wegovy launched as the first GLP-1RA pill for obesity after gaining approval in December 2025, focusing on lowering the entry barrier associated with injection-based treatment. There had been 50,000 prescriptions for the pill by the end of January 2026, and analysts project 400,000 prescriptions in Q1 2026.

The approaching expiry of semaglutide-related patents in some countries is cited as a key risk factor. Chinese biopharmaceutical companies are accelerating development of generics in line with patent expirations, and both Novo Nordisk and Lilly are moving to defend their market shares through price cuts.

Related Articles

References

  1. Wegovy 7.2 mg Wins EU Approval ...Narrowing the Weight-Loss Gap With Mounjaro · www.asiae.co.kr
  2. Novo expands injectable Wegovy offering with European higher dose approval · www.pharmaceutical-technology.com
  3. European Commission greenlights higher-dose Wegovy for obese adults - Indian Pharma Post · www.indianpharmapost.com