Novo Nordisk Fast-Tracks 7.2mg Wegovy Dose for FDA Approval After 20.7% Weight Loss in Trials

Novo Nordisk has moved to secure rapid U.S. Food and Drug Administration (FDA) approval for a higher 7.2 mg dose of its blockbuster obesity drug, Wegovy (semaglutide). The pharmaceutical giant submitted a supplemental New Drug Application (sNDA) utilizing the FDA’s Commissioner’s National Priority Voucher (CNPV) program, which is expected to accelerate the review process to just one to two months. This strategic move aims to enhance Wegovy's efficacy profile in the competitive weight management market. The application is supported by robust data from the 72-week, phase 3 STEP UP clinical trial, involving 1,407 participants. "The 1,407-person trial showed the higher dose delivering 20.7% weight loss over 72 weeks," as stated in the tweet by Bay Area Times. This compares favorably to the 17.5% average weight loss seen with the currently available 2.4 mg dose and 2.4% for placebo, with 33.2% of patients on the 7.2 mg dose achieving at least 25% body weight reduction. The FDA's CNPV program, under which the application is being fast-tracked, is designed to expedite the review of drugs addressing significant unmet medical needs. This voucher was granted to Novo Nordisk earlier this month, allowing for a significantly shorter review period compared to standard pathways. Anna Windle, Novo Nordisk's senior vice president, clinical development, medical and regulatory affairs, noted that this submission "marks an exciting step forward" in meeting the needs of people with obesity. Globally, the 7.2 mg formulation of Wegovy is also under review by regulatory bodies in the UK, the European Union, and other regions. An EU decision is anticipated in the first quarter of 2026. This higher dose is intended for chronic weight management in adults with obesity, alongside a reduced-calorie diet and increased physical activity. The introduction of a more potent Wegovy dose intensifies competition in the GLP-1 weight loss market, particularly against Eli Lilly's Zepbound, which demonstrated 20.2% weight loss in trials. Novo Nordisk's pursuit of a higher-dose Wegovy underscores its commitment to maintaining leadership in the rapidly expanding obesity treatment landscape, with an eye towards setting new benchmarks for efficacy.