European Regulator Approves High-Dose Wegovy from Novo Nordisk
A significant development in the medical field has seen the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) provide a favorable assessment for a higher concentration of Novo Nordisk's obesity treatment, Wegovy, specifically the 7.2 mg semaglutide formulation. This endorsement marks a crucial step for the pharmaceutical company, which has also sought approval from the EMA for a single-dose administration device for this new strength. This expanded dosage option for semaglutide 7.2 mg is simultaneously undergoing regulatory review in various global markets, including the United States and the United Kingdom, indicating a broad international effort to make this treatment accessible.
Clinical trials conducted in the U.S., where Novo Nordisk submitted its application to the FDA in November 2025, have yielded compelling results for the higher dose of Wegovy. Data reveal that patients with obesity, excluding those with diabetes, experienced an average body weight reduction of 20.7% over a 72-week period. These impressive weight loss outcomes are supported by the established health advantages of Wegovy, which include a notable decrease in the likelihood of cardiovascular events such as heart attacks and strokes, alongside a reduction in pain associated with knee osteoarthritis. The positive recommendation from the EMA is underpinned by findings from the extensive STEP UP and STEP UP T2D clinical research programs.
Further analysis of the trial data illustrated that approximately one-third of participants with obesity but without diabetes achieved a weight loss of 25% or more at 72 weeks. This was accomplished with a safety and tolerability profile that mirrored that of the currently approved 2.4 mg semaglutide dose of Wegovy. Importantly, the research highlighted that a substantial portion of the weight reduction (84%) was attributed to the loss of fat mass, with tests confirming the preservation of muscle function, which is a critical aspect of healthy weight management. These advancements signify a promising future for individuals struggling with obesity, offering an effective therapeutic pathway to improve their health and well-being.
The progressive steps taken by regulatory bodies to approve advanced treatments like high-dose Wegovy highlight a global commitment to addressing public health challenges such as obesity. By endorsing therapies that provide significant weight reduction and associated health benefits, these decisions pave the way for enhanced patient care and improved quality of life. Such medical innovations embody a spirit of hope and progress, continually striving to bring positive change and better health outcomes to communities worldwide.