Global pharma giant Novo Nordisk has moved to widen its obesity-treatment arsenal, filing a supplemental New Drug Application with the U.S. Food and Drug Administration for a higher 7.2 mg dose of semaglutide. 

 

The drug, intended for chronic weight management alongside diet and exercise, is now under the FDA’s new CNPV expedited review pathway, with a decision expected just 1–2 months after the filing is accepted.

 

"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, 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 submission leans heavily on results from STEP UP, a 72-week phase 3 superiority trial including 1,407 adults with obesity but not diabetes. The study compared once-weekly semaglutide 7.2 mg with both placebo and the already-approved 2.4 mg dose.

 

As with other GLP-1 drugs, gastrointestinal side effects were more common at the higher dose, and dysaesthesia was also reported more frequently. Serious adverse events occurred in 6.8% of participants taking semaglutide 7.2 mg, 10.9% on the 2.4 mg dose, and 5.5% on placebo.

 

The 7.2 mg dose of Wegovy is also under review with the European Medicines Agency, UK regulators, and authorities in several other countries, with an EU decision expected in early 2026.