Novo Nordisk recently took a significant step in expanding its chronic weight management treatment portfolio by submitting a supplemental marketing application to the U.S. Food and Drug Administration (FDA). This application seeks approval for a new, higher dose of its semaglutide injection, Wegovy, specifically 7.2 mg, building on the success of its existing 2.4 mg formulation.
This initiative follows a parallel review process in Europe, where the European Medicines Agency, along with regulatory bodies in the U.K. and other countries, is already evaluating the 7.2 mg dose. Novo Nordisk projects a regulatory decision from the EU in the first quarter of 2026. The FDA's review, facilitated by the Commissioner's National Priority Voucher (CNPV) expedited program, is anticipated to conclude within one to two months after the agency accepts the filing.
The application for this higher dose is bolstered by robust findings from the STEP UP clinical trial, a 72-week, phase 3 study. This trial rigorously assessed the effectiveness and safety of once-weekly semaglutide 7.2 mg against both a placebo and the established semaglutide 2.4 mg dose in a cohort of 1,407 adults suffering from obesity, explicitly excluding individuals with diabetes. The results showcased a remarkable average weight reduction of 20.7% in patients receiving the 7.2 mg dose, significantly surpassing the 17.5% achieved with the 2.4 mg dose and a mere 2.4% in the placebo group. Furthermore, a substantial 33.2% of participants on the higher dose achieved a weight loss of 25% or more, a notable improvement over the 16.7% for the 2.4 mg dose and zero percent for placebo, highlighting the enhanced efficacy of the new formulation.
This development signifies a promising advancement in the treatment of obesity, offering a more potent option for individuals seeking effective chronic weight management. The positive outcomes from the STEP UP trial underscore the potential of this higher-dose semaglutide to significantly improve health outcomes and quality of life for a broad patient population. The expedited review by regulatory bodies reflects the urgent need and high anticipation for such innovative therapeutic solutions in addressing the global health challenge of obesity.