The U.S. Food and Drug Administration (FDA) granted an indication extension approval last week to Novo Nordisk (NYSE: NVO) for its GLP-1 receptor agonist Wegovy (semaglutide), allowing it to be used for the reduction of major adverse cardiovascular events (MACE) in overweight or obese adults with established cardiovascular disease (CVD). This makes Wegovy the first treatment approved in the U.S. for both weight management and the reduction of cardiovascular risks. A similar indication filing in Europe is anticipated to complete its review later this year.
The FDA’s decision is supported by Phase III data indicating that the addition of Wegovy to standard care resulted in a 20% reduction in the risk of MACE and a 15% decrease in cardiovascular death over five years compared to placebo. However, Novo Nordisk acknowledged that the specific mechanism by which Wegovy reduces cardiovascular risk remains unestablished.- Flcube.com
