- Novo Nordisk submitted a sNDA to the FDA for semaglutide 7.2 mg.
- The FDA review is expected within 1–2 months after filing acceptance.
- Phase 3 trial showed 20.7% average body weight loss with semaglutide 7.2 mg.
FDA Submission
Novo Nordisk has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a higher dose of semaglutide injection, 7.2 mg. This dose is intended for chronic weight management in adults with obesity, to be used alongside a reduced-calorie diet and increased physical activity.
Expedited Review
The application will be reviewed under the FDA’s Commissioner’s National Priority voucher (CNPV) pilot program, which accelerates the review process for products addressing major national health priorities. The review is expected to be completed within 1–2 months following the FDA’s acceptance of the filing.
Clinical Trial Results
In the STEP UP phase 3 trial, adults with obesity who took semaglutide 7.2 mg as directed experienced an average body weight loss of 20.7%. This data supports the potential of the higher dose to offer greater weight loss options for patients.
