The U.S. Food and Drug Administration (FDA) has approved a new indication for Novo Nordisk’s Ozempic® (semaglutide) injection 0.5 mg or 1 mg to reduce the risk of major adverse cardiovascular events (MACE) such as heart attack, stroke, or death in adults with Type 2 diabetes and known heart disease.
Cardiovascular disease (CVD) is the main cause of death and disability among people withy Type 2 diabetes. Adults with type 2 diabetes are two to four times more likely to develop CVD than adults without diabetes.
The FDA’s decision on Ozempic® is based on results from the SUSTAIN 6 cardiovascular outcomes trial (CVOT) which examined the cardiovascular safety of adding Ozempic® or placebo to the standard of care in adults with type 2 diabetes and established cardiovascular disease.
In the trial, Ozempic® significantly reduced the risk of the occurrence of a three-component MACE endpoint consisting of cardiovascular death, non-fatal heart attack or non-fatal stroke.
“There is a well-established link between cardiovascular disease and type 2 diabetes,” said Todd Hobbs, vice president, and U.S. chief medical officer of Novo Nordisk. “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 CV event remains.”
Additional details have also been added to the Rybelsus® (semaglutide) tablets 7 mg or 14 mg Prescribing Information label also.
- Novo Nordisk. (2020, Jan. 16). FDA approves Ozempic® for cardiovascular risk reduction in adults with type 2 diabetes and known heart disease, updates Rybelsus® label. PR Newswire. Retrieved Jan. 17, 2020 from https://prnmedia.prnewswire.com/news-releases/fda-approves-ozempic-for-cardiovascular-risk-reduction-in-adults-with-type-2-diabetes-and-known-heart-disease-updates-rybelsus-label-300988672.html