Wegovy (semaglutide 7.2 mg)
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Novo Nordisk Wants FDA Nod For A Higher-Dose Wegovy
Benzinga· 2025-11-26 18:27
Core Viewpoint - Novo Nordisk has submitted a supplemental marketing application to the FDA for a higher dose of semaglutide injection (7.2 mg) aimed at chronic weight management, with expectations for regulatory decisions in various regions, including the EU by Q1 2026 [1][2]. Group 1: Application Details - The application includes results from the STEP UP trial, a 72-week phase 3 study that assessed the efficacy and safety of semaglutide 7.2 mg against placebo and semaglutide 2.4 mg in 1,407 adults with obesity [3]. - Patients with diabetes were excluded from the trial [3]. Group 2: Trial Results - Participants treated with semaglutide 7.2 mg experienced an average weight loss of 20.7% after 72 weeks, compared to 17.5% for semaglutide 2.4 mg and 2.4% for placebo, starting from a mean baseline weight of 249 pounds [4]. - 33.2% of patients on semaglutide 7.2 mg achieved a weight loss of 25% or more, compared to 16.7% for semaglutide 2.4 mg and 0.0% for placebo [4]. Group 3: Additional Findings - When including participants who discontinued, those on semaglutide 7.2 mg achieved an 18.7% weight loss, while semaglutide 2.4 mg and placebo resulted in 15.6% and 3.9% weight loss, respectively [5]. - 90.7% of participants on semaglutide 7.2 mg achieved at least a 5% reduction in body weight, compared to 89.9% for semaglutide 2.4 mg and 36.8% for placebo [5]. - 31.2% of those receiving semaglutide 7.2 mg achieved a weight loss of 25% or more, compared to 15.3% for semaglutide 2.4 mg and 0.0% for placebo [6]. Group 4: Market Reaction - Following the news, Novo Nordisk shares rose by 3.77%, reaching $48.83 at the time of publication [6].