The U.S. Food and Drug Administration approved a higher dose of Novo Nordisk’s semaglutide for weight loss on March 19, marking the fourth approval under its Commissioner’s National Priority Voucher program.
The new formulation, called Wegovy HD, is a 7.2 mg injectable dose designed to offer greater weight loss than previous versions. The FDA approved the drug just 54 days after Novo Nordisk filed a supplemental new drug application in November 2025. According to Novo Nordisk, the company plans to launch Wegovy HD in the United States in April.
The Commissioner’s National Priority Voucher (CNPV) program was introduced in June 2025 to speed up review times for drugs that address national priorities such as public health crises or affordability. The goal is to reduce review periods from up to a year down to one or two months for qualifying products.
According to the FDA, the approval of Wegovy HD “will provide adult patients with an additional therapeutic option offering the potential for greater weight loss.” Data from clinical trials showed that patients using Wegovy HD lost an average of 20.7% of their body weight after 72 weeks, compared with a 17.5% reduction for those taking semaglutide 2.4 mg and a 2.4% reduction for placebo when patients adhered to treatment. In another trial involving patients with obesity and type 2 diabetes, those treated with Wegovy HD experienced an average weight loss of 14.1%. Safety data indicated that gastrointestinal side effects and unusual touch sensations were more common at the higher dose, but severe adverse effects occurred less frequently than with some lower doses.
Wegovy HD is the first GLP-1 treatment approved through the CNPV program. Eli Lilly also holds a priority voucher for its oral weight loss pill orforglipron, with an FDA decision expected soon.
Novo Nordisk said Thursday that this approval “underscore(s) its potential to address critical patient needs and national health priorities in the US.” However, neither Novo nor the FDA specified which national priority was met by this product.
