PLAINSBORO, N.J. — Novo Nordisk has submitted a supplemental New Drug Application to the Food and Drug Administration for a higher 7.2 mg dose of its once-weekly Wegovy (semaglutide) injection, aiming to provide U.S. adults with obesity a more effective option for chronic weight management. The submission will be reviewed under the FDA’s new expedited Commissioner's National Priority voucher pilot, which is designed to speed up review for products addressing major national health priorities.
If accepted, the agency is expected to complete its review within one to two months.
“Our pipeline is rapidly expanding to meet the needs of people living with obesity, and this submission — under the FDA’s new expedited review program — marks an exciting step forward,” said Anna Windle, PhD, senior vice president of clinical development, medical and regulatory affairs at Novo Nordisk. “If approved, semaglutide 7.2 mg would bring patients and healthcare professionals a new option for greater weight loss potential, further underlining the efficacy that the semaglutide molecule can bring. We look forward to working with the FDA to bring this fast-tracked option to the obesity community.”
The higher dose is supported by new results from STEP UP, a 72-week phase 3 superiority trial involving 1,407 adults with obesity but no diabetes. Starting with a mean baseline weight of 249 pounds, patients taking semaglutide 7.2 mg as directed achieved an average weight loss of 20.7% after 72 weeks, compared to 17.5% for the standard 2.4 mg dose and 2.4% for placebo.
Over 33% of participants on the 7.2 mg dose lost at least 25% of their body weight, nearly twice the rate of 16.7% seen with the 2.4 mg dose. When including all participants, even those who stopped treatment, the average weight loss was 18.7% with semaglutide 7.2 mg, compared to 15.6% for 2.4 mg and 3.9% for placebo.
Overall, 90.7% of patients taking the 7.2 mg dose achieved at least 5% weight loss, similar to the 2.4 mg dose but significantly higher than the 36.8% with placebo.
Gastrointestinal side effects and dysesthesia were more frequently reported with the higher dose. Serious adverse events occurred in 6.8% of those treated with semaglutide 7.2 mg, compared to 10.9% for 2.4 mg and 5.5% for placebo.
The 7.2 mg dose is currently under review in Europe, the United Kingdom, and several other countries. A regulatory decision from the European Medicines Agency is expected in early 2026.
Obesity affects over 40% of U.S. adults and is recognized as a chronic, biologically driven disease that requires long-term management. Novo Nordisk stated that demand for more effective and flexible treatment options continues to grow as GLP-1–based therapies reshape the obesity treatment landscape.
