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Novo Nordisk has submitted sNDA to the U.S. Food and Drug Administration (FDA) to approve a significantly more potent version of its popular weight-loss drug, Wegovy®. The pharmaceutical company announced Wednesday that it has submitted a Supplemental New Drug Application (sNDA) for a weekly semaglutide injection of 7.2 mg. This is three times the strength of the currently approved maximum maintenance dose of 2.4 mg. The higher dose is intended for chronic weight management in adults with obesity, to be used in conjunction with a reduced-calorie diet and increased physical activity. In a significant development for the timeline of potential availability, Novo Nordisk confirmed that the submission is being reviewed under the FDA’s Commissioner’s National Priority Voucher (CNPV) program. This expedited pathway allows for a drastically accelerated review process. The company anticipates a regulatory decision within just one to two months following the FDA’s formal acceptance of the filing. STEP UP Trial Shows Greater Weight Loss Potential The application is bolstered by results from the Phase 3 STEP UP trial, a 72-week, randomized, double-blind study involving 1,407 adults with obesity (BMI ≥30 kg/m2). The trial specifically excluded patients with diabetes to isolate the drug's effect on obesity alone. The trial was designed to show superiority of the 7.2 mg dose over both placebo and the standard Wegovy 2.4 mg dose. The results demonstrated a clear dose-response relationship, suggesting that higher levels of semaglutide yield greater weight reduction. Read More: Novo Nordisk’s Amycretin Shows Significant Efficacy in Phase 2 Trial, Demonstrating Major Weight Loss and HbA1c Reduction in Type 2 Diabetes According to the trial data, participants started with a mean baseline body weight of 249 pounds. When looking at patients who strictly adhered to the treatment regimen for the full 72 weeks: Those taking semaglutide 7.2 mg achieved an average weight loss of 20.7%. Those taking the current semaglutide 2.4 mg dose saw a reduction of 17.5%. The placebo group saw a reduction of 2.4%. Crucially for those requiring significant weight reduction, one-third (33.2%) of patients on the new high dose achieved weight loss of 25% or more of their body weight, double the rate (16.7%) observed in the 2.4 mg group. The study also offered a "real-world" view that included data from patients who discontinued treatment during the trial. Even in this analysis, the 7.2 mg dose outperformed the lower dose, showing an 18.7% average weight loss compared to 15.6% for the 2.4 mg version. Safety and Tolerability Profile While the efficacy data points to higher weight loss, the trial indicated that increased potency comes with a higher incidence of certain side effects. Novo Nordisk reported that gastrointestinal adverse events known side effects of GLP-1 receptor agonists like semaglutide were more common with the 7.2 mg dose compared to the 2.4 mg dose or placebo. The company also noted that dysaesthesia, a condition involving abnormal cutaneous sensations such as tingling or burning, was more frequently reported in the high-dose group. However, the data showed that serious adverse events were reported by fewer participants in the high-dose group (6.8%) than in the standard dose group (10.9%), though higher than placebo (5.5%). Information: Novo Nordisk Last Modified:

Tag: NDA

Novo Nordisk Seeks FDA Approval for “Super-Charged” Wegovy Dose; Review Expedited Under New Priority Program

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