Novo Nordisk Gains EU Approval for Higher-Dose Weight-Loss Treatment

Novo Nordisk DK0062498333

The European Commission has granted Novo Nordisk authorization to market a higher maintenance dose of its anti-obesity medication, Wegovy. Physicians across all 27 member states can now prescribe a 7.2 mg dose, marking a significant regulatory milestone for the Danish pharmaceutical giant in the competitive obesity drug sector.

This new approval is intended for adults living with obesity who require additional weight loss following standard treatment with the 2.4 mg dose. Currently, achieving the 7.2 mg level requires three consecutive weekly injections of 2.4 mg each. In a related development, Novo Nordisk has submitted a separate application for a dedicated 7.2 mg prefilled pen, which could potentially reach the market by the end of 2026.

The regulatory decision is supported by data from the Phase III STEP UP trial, which involved 1,407 participants. Results showed that, on average, subjects lost 21 percent of their body weight, a stark contrast to the approximately 2 percent reduction observed in the placebo group. Notably, about one-third of trial participants achieved weight loss of at least 25 percent. According to the company, 84 percent of the lost mass constituted fat, while muscle function was preserved.

Strategic Move in a Competitive Landscape

The EU green light arrives at a pivotal moment for Novo Nordisk, which faces intensifying rivalry from Eli Lilly?s tirzepatide, marketed in Europe as Mounjaro for obesity. The introduction of a higher-dose Wegovy is viewed as a strategic initiative to strengthen the company's market position.

The 7.2 mg variant of Wegovy has been available in the United Kingdom since January 2026. Applications with the U.S. Food and Drug Administration (FDA) and other international regulatory bodies remain pending. Beyond injectables, Novo Nordisk is also advancing its oral Wegovy tablet, which launched in the United States in January 2026 as the first GLP-1 pill for obesity. The company reported 50,000 prescriptions for the tablet form by the end of January.

A Broader Dosage Range

With this latest regulatory endorsement, Wegovy is now available in the European Union across six different dosage strengths: 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg, and the newly approved 7.2 mg. The medication is approved for chronic weight management as an adjunct to a reduced-calorie diet and increased physical activity in adults with obesity, or those who are overweight and have at least one weight-related comorbid condition.