Novo Nordisk Says EMA Issues Positive Opinion For New Wegovy 7.2 mg Dose, Supporting Substantial Weight Loss In STEP UP Programme

Benzinga · 2d ago
  • The European Medicines Agency (EMA) has issued a positive opinion for a new Wegovy® 7.2 mg dose, advancing its availability in the European Union (EU)
  • In the STEP UP programme, people with obesity taking Wegovy® 7.2 mg lost an average of 20.7% body weight at 72 weeks; one in three people achieved 25% or more weight loss*
  • The higher dose adds a new option for substantial weight loss while preserving muscle function and maintaining the established cardiovascular health benefits of Wegovy

Bagsværd, Denmark, 12 December 2025 – Today, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for a higher dose of Wegovy® (semaglutide 7.2 mg), bringing it a step closer to offering individuals with obesity in the EU a new Wegovy® option for even greater weight loss. The new dose of Wegovy® has demonstrated an average weight loss of 20.7% at 72 weeks, in people with obesity who do not have diabetes.1* These substantial weight loss results complement the already established health benefits of Wegovy® in obesity-related complications, including significant reduction in the risk of cardiovascular events such as heart attack and stroke, and reduction in pain from knee osteoarthritis.2,3

The positive opinion is based on the results from the STEP UP and STEP UP T2D clinical trial programme in people with obesity with and without type 2 diabetes.1,4 In people with obesity and without diabetes, one in three participants treated with Wegovy® achieved 25% or more weight loss at 72 weeks, with a safety and tolerability profile consistent with the approved Wegovy® 2.4 mg semaglutide dose.1 Data showed that the majority (84%) of the weight lost with Wegovy® came from fat mass loss, with tests confirming muscle function was preserved.