Novo Nordisk has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for a higher 7.2 mg dose of its semaglutide injection for chronic weight management in adults with obesity.
If approved, the investigational 7.2 mg semaglutide injection would give doctors and patients an option for greater weight‑loss potential when used alongside a reduced-calorie diet and increased physical activity.
The application is being reviewed under the FDA’s expedited programme for priority public‑health therapies, with regulatory review expected within one to two months of acceptance.
The filing is supported by data from the 72‑week Phase‑3 trial under the name STEP UP trial. In that trial, adults treated with semaglutide 7.2 mg lost an average of 20.7% of their body weight — a substantial reduction compared with lower doses or placebo, when combined with lifestyle modification.
Novo Nordisk describes this filing as a significant advance for obesity care, positioning the higher-dose semaglutide injection as a potential new tool in long-term weight management, pending regulatory approval.
