Novo Nordisk announced its plan to use its Commissioner’s National Priority Review Voucher (CNPV) on its 7.2 mg Wegovy injectable, intended for use with a reduced calorie diet and increased physical activity for chronic weight management in adults with obesity.

The company submitted its supplemental New Drug Application (sNDA) for its higher dose semaglutide injectable for review to FDA and under the CNPV, the review process is expedited to just 1-2 months, following FDA’s approval of the sNDA.¹

"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."

FDA’s Commissioner’s Priority Review Program

Wegovy was named as one of the first 15 drugs in the priority review pilot program, granting Novo Nordisk the ability to obtain a voucher that enables FDA to accelerate the drug review process from 10-12 months to just 1-2 months.²

Other drugs included in the program include:

• Pergoveris for infertility
• Teplizumab for Type I diabetes
• Cytisinicline for nicotine vaping addiction
• DB-OTO for deafness
• Cenegermin-bkbj for blindness
• RMC-6236 for pancreatic cancer
• Bitopertin for porphyria
• Ketamine for domestic manufacturing of a critical drug for general anesthesia
• Augmentin XR for domestic manufacturing of a common antibiotic
• Hernexeos for HER2 lung cancer
• Sirturo for drug-resistant tuberculosis in young children
• Jemperli for rectal cancer
• Casgevy or sickle cell disease
• Orforglipron for obesity and related health conditions

What were the results of the Phase III STEP UP trial?

The sNDA includes results from the Phase III STEP UP trial, a randomized, double-blind, placebo-controlled and active-controlled superiority trial, evaluating the efficacy and safety of once-weekly semaglutide 7.2 mg injectables, compared to both placebo and semaglutide 2.4 mg, as an adjunct to lifestyle intervention.¹ The study’s primary objective was to demonstrate superiority of semaglutide 7.2 mg against placebo with respect to the percentage change in body weight, along with the proportion of participants with weight loss of 5% or greater.¹

Other findings from the study showed that gastrointestinal adverse events were more common with semaglutide 7.2 mg compared to 2.4 mg or placebo, as was dysaesthesia.¹ Additionally, 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.2

The confirmatory secondary endpoints of the study included measuring the proportion of participants reaching greater than or equal to 10%, 15%, 20% and 25% weight loss with semaglutide 7.2 mg compared to those who were administered the placebo. The trial was conducted over a 72-week period and included a patient population of 1,407 adults with obesity while patients with diabetes were excluded.¹

Sources

1. Novo Nordisk files for FDA approval of a higher dose of Wegovy® injection 7.2 mg PR Newswire.November 26, 2025. https://www.prnewswire.com/news-releases/novo-nordisk-files-for-fda-approval-of-a-higher-dose-of-wegovy-injection-7-2-mg-302626162.html

2. FDA Continues to Expand National Priority Voucher Program. Pharmaceutical Executive. November 7, 2025. https://www.pharmexec.com/view/fda-expand-national-priority-voucher-program