Novo Nordisk files submission to FDA for approval of a higher dose of Wegovy (semaglutide) injection 7.2 mg

Novo Nordisk announced the submission of a sNDA to the U.S. Food and Drug Administration (FDA) for a higher dose of semaglutide injection 7.2 mg, to be used along with a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity. Under the CNPV expedited program, review is expected within 1–2 months following the FDA’s acceptance of the filing.

“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, Clinical Development, Medical and Regulatory Affairs, 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 sNDA includes results from STEP UP, a 72-week phase III, randomized, double-blind, placebo controlled and active-controlled superiority trial that evaluated the efficacy and safety of once-weekly semaglutide 7.2 mg compared to placebo and semaglutide 2.4 mg, as an adjunct to lifestyle intervention, in 1,407 adults with obesity (BMI ≥30 kg/m²). Patients with diabetes were excluded.

From a mean baseline body weight of 249 pounds, people treated with semaglutide 7.2 mg in the STEP UP trial achieved an average weight loss of 20.7% after 72 weeks compared to a reduction of 17.5% with semaglutide 2.4 mg and 2.4% with placebo, when patients adhered to treatment. In addition, 33.2% of those who received semaglutide 7.2 mg achieved a weight loss of 25% or more after 72 weeks, compared to 16.7% with semaglutide 2.4 mg and 0.0% with placebo. When assessed to include those who discontinued, people treated with semaglutide 7.2 mg achieved weight loss of 18.7% compared to a reduction of 15.6% with semaglutide 2.4 mg and 3.9% with placebo. 90.7% of participants taking semaglutide 7.2 mg achieved a body weight reduction of greater than or equal to 5%, compared to 89.9% and 36.8% for semaglutide 2.4 mg and placebo, respectively. Also, 31.2% of those who received semaglutide 7.2 mg achieved a weight loss of 25% or more after 72 weeks, compared to 15.3% for semaglutide 2.4 mg and 0.0% for placebo.

Gastrointestinal adverse events were more common with semaglutide 7.2 mg versus 2.4 mg or placebo, as was dysaesthesia. Serious adverse events were reported by 6.8% of participants with semaglutide 7.2 mg, 10.9% with semaglutide 2.4 mg, and 5.5% with placebo.

The new, higher dose of Wegovy (semaglutide 7.2 mg) is currently under review with the European Medicines Agency (EMA), in the UK and several other countries. In the EU, Novo Nordisk expects a regulatory decision in Q1 2026.