Danish pharmaceutical company Novo Nordisk A/S (CPH:NOVO-B) (NYSE:NVO) announced on Wednesday that it has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for a higher dose of semaglutide injection 7.2mg to be used along with a reduced calorie diet and increased physical activity for chronic weight management in adults with obesity.

This application will be reviewed under the FDA's Commissioner's National Priority voucher (CNPV) pilot, which accelerates review for products addressing major national health priorities. The review is expected within 1-2 months following the FDA's acceptance of the filing.

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 greater than or equal to 30 kg/m2).

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