FDA Approves Higher-Dose Wegovy for Obesity

The U.S. Food and Drug Administration approved a higher-dose version of Novo Nordisk's Wegovy obesity treatment on Thursday, expanding options for patients seeking greater weight loss through weekly injections of the drug semaglutide. The new formulation increases the maximum dose from 2.4 milligrams to 7.2 milligrams, targeting individuals who do not achieve sufficient results on the standard regimen.

The approval came under the FDA's new national priority voucher program, an expedited review process launched in June to address critical health needs like obesity. Regulators granted clearance just 54 days after receiving the application, marking the first use of this initiative. Novo Nordisk, based in Denmark, plans to launch the higher-dose injection in U.S. pharmacies as early as April, with pricing details to follow.

Clinical trials supported the decision, showing that participants on the 7.2-milligram dose lost an average of 19 to 20.7 percent of their body weight over 72 weeks, or about 17 months, compared to roughly 15 to 16 percent on the 2.4-milligram dose. In one study, this translated to nearly 47 pounds lost versus 39 pounds on the lower dose. For patients with both...