New higher-dose Wegovy approved in Europe after study shows 21% weight loss

Dubai: European regulators have approved a stronger maintenance dose of the weight-loss drug Wegovy, giving doctors across the European Union a new option to support patients struggling to achieve sufficient results on existing treatment levels.

The European Commission granted final clearance for a 7.2 mg once-weekly dose of the injectable semaglutide therapy, following a positive scientific opinion issued by the European Medicines Agency’s committee in December. The decision applies across all 27 EU member states and marks the latest expansion of treatment choices within the rapidly growing obesity management market.

The new dosage is designed primarily for adults who require additional weight reduction after completing treatment on the existing 2.4 mg dose, while continuing lifestyle interventions including dietary changes and physical activity.

Clinical trials show significant weight reduction

Approval was based on large-scale clinical trials involving nearly 2,000 participants, which demonstrated substantial weight loss outcomes compared with placebo treatment.

In one of the main studies involving 1,407 adults living with obesity, participants receiving the higher dose over approximately 18 months recorded an average reduction of about one fifth of their body weight. Roughly one in three participants achieved weight loss exceeding 25%, a level considered clinically significant in long-term obesity treatment.

Researchers also found improvements in body composition, with about 84% of total weight loss attributed to fat mass while muscle function was largely preserved, a key factor in maintaining metabolic health.

The most commonly reported side effects included gastrointestinal symptoms such as nausea, diarrhoea and vomiting, alongside sensory disturbances. These effects were generally described as mild to moderate and temporary.

Expanded dosing flexibility for physicians

The newly approved regimen allows the 7.2 mg weekly dose to be administered through three injections of the existing 2.4 mg formulation taken during the same treatment session. A single-dose pen for the higher strength is currently under regulatory review in Europe and could become available later this year.

The drug is already authorised in the United Kingdom at the higher dosage level, while approval applications are under review in the United States and other markets.

Emil Kongshøj Larsen, Executive Vice President for International Operations at Novo Nordisk, said the decision represents an important step in broadening treatment pathways.

"This approval is another important step in helping people living with obesity reach very significant weight loss. The new dose gives healthcare professionals even more flexibility to tailor treatment and help people with obesity achieve their weight loss and health goals."

Growing demand reshapes obesity treatment landscape

The approval comes amid rising global demand for pharmaceutical weight-management therapies, driven by increasing obesity prevalence and growing awareness of associated health risks including diabetes, cardiovascular disease and metabolic disorders.

Wegovy is now authorised in the European Union across multiple dosing levels ranging from 0.25 mg to 7.2 mg, positioning the therapy among the most flexible treatment options currently available in the obesity care market.