更高效剂量的Wegovy注射液获欧盟委员会批准

Core Viewpoint - The European Commission has approved a new 7.2 mg weekly maintenance dose of Wegovy® (semaglutide injection) for adult obesity patients, providing a new treatment option for those needing additional weight loss after using the 2.4 mg dose [1] Group 1: Approval and Market Impact - The approval allows EU doctors to prescribe the 7.2 mg dose, which involves a single injection of three 2.4 mg doses weekly [1] - Novo Nordisk has submitted a marketing authorization application for the 7.2 mg single-dose injection pen in the EU, with potential market entry expected this year [1] - Wegovy® 7.2 mg has already been approved and launched in the UK, with ongoing reviews by the FDA and other regulatory bodies in various countries [1] Group 2: Clinical Study Results - Two clinical studies, STEP UP (1,407 participants) and STEP UP T2D (512 participants), showed that participants receiving the 7.2 mg dose with lifestyle interventions lost significantly more weight than those on placebo [2] - In non-diabetic adult obesity participants, the Wegovy® 7.2 mg group achieved an average weight loss of 21%, compared to approximately 2% in the placebo group [3] - About one-third of patients achieved a weight loss of 25% or more, with 84% of the weight loss coming from fat mass, while muscle function was preserved [4] Group 3: Side Effects and Expert Commentary - The most common adverse reactions included nausea, diarrhea, vomiting (24.8%), and abnormal sensations (22.9%), which were generally mild to moderate and transient [4] - The executive vice president of Novo Nordisk emphasized that this approval represents a significant advancement in helping the obese population achieve more substantial weight loss, offering greater flexibility for healthcare professionals to tailor treatment plans [4]