Novo Nordisk Jan. 16 announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for 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.1 Additional details were added to the Rybelsus® (semaglutide) tablets 7 mg or 14 mg Prescribing Information about the primary analysis for PIONEER 6.
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 standard of care in adults with type 2 diabetes and established cardiovascular disease. In the 2-year SUSTAIN 6 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. 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,” said Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk. “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.”