The European Union’s medicines regulator has endorsed a higher dose of Novo Nordisk’s weight-loss drug Wegovy, marking a significant development in obesity treatment across Europe. The decision reflects growing regulatory confidence in stronger medical therapies to address rising obesity rates.
The European Medicines Agency’s scientific committee issued a positive opinion for a 7.2 milligram weekly dose, which delivers substantially greater weight loss than the currently approved formulation. The recommendation positions the higher dose for final review by the European Commission.
Novo Nordisk said the move could expand treatment options for patients who struggle to achieve meaningful results with existing doses. If the European Commission grants approval, the company expects the new formulation to become available in the European Union early next year.
The regulator based its opinion on results from a large late-stage clinical trial involving more than 1,400 adults without diabetes who were classified as obese. Participants receiving the higher dose lost an average of 20.7 per cent of their body weight over a 72-week period. This outcome exceeded the weight loss typically seen with the currently approved 2.4 milligram dose.
Trial data showed that most of the weight reduction came from body fat rather than muscle. Researchers reported that about 84 per cent of the weight lost was fat mass, while muscle function remained largely intact. This finding is considered important because preserving muscle strength reduces the risk of frailty and physical decline.
The study also showed that roughly one in three participants achieved weight loss of at least 25 per cent. Medical experts say this level of reduction approaches outcomes usually associated with surgical interventions, but without the need for invasive procedures.
Novo Nordisk said the higher dose could help address the needs of patients who have struggled to lose enough weight using existing medications. Obesity is linked to serious health conditions, including heart disease, stroke, type 2 diabetes and joint disorders. More effective treatments could reduce long-term health risks and ease pressure on healthcare systems.
The company added that Wegovy has already demonstrated benefits beyond weight loss, including reduced cardiovascular risk in certain patients. Novo Nordisk said it expects the higher dose to build on those outcomes while offering doctors greater flexibility when tailoring treatment plans.
The EMA’s recommendation now goes to the European Commission for formal approval. While the process can take several weeks, approvals typically follow the agency’s guidance. Once cleared, Novo Nordisk plans to roll out the higher dose gradually, subject to national pricing and reimbursement decisions.
Novo Nordisk is also seeking approval for the higher dose in other major markets. The company has filed applications in the United States and the United Kingdom, reflecting strong global demand for effective obesity drugs.
The obesity drug market has grown rapidly in recent years, driven by rising demand and increased awareness of obesity as a chronic disease rather than a lifestyle issue. Novo Nordisk’s Wegovy and Eli Lilly’s competing treatments have dominated the market, with both companies racing to develop more powerful and longer-lasting options.
Competition has intensified as pharmaceutical firms invest heavily in next-generation obesity therapies. Analysts say higher-dose formulations could help manufacturers maintain market share while delivering stronger clinical outcomes.
The EMA committee also issued other recommendations related to metabolic disease treatments during the same meeting. Among them was support for expanding the use of Eli Lilly’s diabetes drug Mounjaro for children and adolescents with type 2 diabetes, highlighting broader regulatory momentum in the field.
For patients, the prospect of a higher Wegovy dose offers renewed hope, especially for those who have seen limited progress on existing therapies. Doctors say having access to a more potent option could improve long-term weight management and reduce obesity-related complications.
Health experts caution that medication works best when combined with lifestyle changes such as improved diet and physical activity. Still, they note that effective drugs can play a critical role for people who face biological or medical barriers to weight loss.
The EMA’s support marks another milestone in the evolving treatment of obesity in Europe. As regulators move toward final decisions, healthcare providers and patients alike are watching closely. Approval of the higher Wegovy dose would signal a significant step forward in addressing one of the region’s most persistent public health challenges.
