Novo Nordisk announced the submission of a supplemental New Drug Application (sNDA) to the US 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 Commissioner’s National Priority Voucher (CNPV) expedited programme, review is expected within one to two 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 programme—marks an exciting step forward. 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," said Anna Windle, PhD, Senior Vice President—Clinical Development, Medical and Regulatory Affairs, Novo Nordisk.

The sNDA includes results from STEP UP, a 72-week phase 3, randomised, 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.

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 percent of participants with semaglutide 7.2 mg, 10.9 percent with semaglutide 2.4 mg, and 5.5 percent 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 European Union (EU), Novo Nordisk expects a regulatory decision in Q1 2026.