Novo Nordisk A/S: More efficacious dose of Wegovy® recommended by the European Medicines Agency can help people with obesity achieve an average of 20.7% weight loss

Core Viewpoint - The European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion for a higher dose of Wegovy (semaglutide 7.2 mg), which could provide individuals with obesity in the EU a new option for significant weight loss, demonstrating an average weight loss of 20.7% at 72 weeks [1][7]. Summary by Sections Clinical Trial Results - The positive opinion is based on the STEP UP and STEP UP T2D clinical trial programs, showing that one in three participants treated with Wegovy achieved 25% or more weight loss at 72 weeks [2][3]. - In the STEP UP trial, 1,407 adults with a BMI ≥30 kg/m² without diabetes participated, confirming the efficacy and safety of semaglutide 7.2 mg compared to semaglutide 2.4 mg and placebo [5]. - The majority (84%) of the weight lost with Wegovy was from fat mass, with preserved muscle function [2][5]. Health Benefits - Wegovy has proven health benefits in obesity, including significant reductions in the risk of cardiovascular events such as heart attack and stroke, and alleviation of pain from knee osteoarthritis [1][8]. - The new higher dose aims to enhance weight loss while maintaining the established cardiovascular health benefits of Wegovy [7]. Regulatory and Market Implications - The new Wegovy option could be available early in the new year, pending final approval from the European Commission [3]. - Novo Nordisk has also applied for a single-dose device to deliver Wegovy 7.2 mg and is seeking approval in the US, UK, and other countries [3][9].