FDA clears new indication for Novo Nordisk’s Ozempic

Novo Nordisk has obtained the Food and Drug Administration’s blessing for a new indication for Ozempic (semaglutide injection). The drug now is approved to reduce the risk of major adverse cardiovascular events, including heart attack, stroke, or death, in adults with Type 2 diabetes and known heart disease.

Ozempic already is indicated along with diet and exercise to improve blood glucose levels in adults with Type 2 diabetes and to reduce the risk of such major cardiovascular events as heart attack, stroke or death in adults with Type 2 diabetes with known heart disease.

"There is a well-established link between cardiovascular disease and Type 2 diabetes. It's one of our biggest concerns with Type 2 diabetes because even when patients reach their blood sugar targets, the risk of a major adverse [cardiovascular] event remains," said Todd Hobbs, Novo Nordisk vice president and U.S. chief medical officer. "Today's milestone establishes Ozempic as an option for patients to help address two critical aspects of managing Type 2 diabetes, blood sugar control and cardiovascular risk reduction, in those with known heart disease."