FDA approved a cardiovascular indication for a major diabetes drug—the second in the past 6 months.
FDA cleared a new indication for semaglutide (Ozempic, Novo Nordisk) 0.5 mg. or 1 mg. injection 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.
Ozempic’s expanded indication comes 6 months after FDA granted Fast Track designation to empagliflozin (Jardiance, Boehringer Ingelheim and Eli Lilly and Company) to reduce the risk of cardiovascular death and hospitalization for heart failure in people with chronic heart failure.
“The approval of Ozempic is important because there is a well-established link between cardiovascular disease and type 2 diabetes. It’s one of our biggest concerns with type 2 diabetes and known heart disease because even when patients reach their blood sugar targets, the risk of a major adverse CV event remains,” Todd Hobbs, vice president and US chief medical officer of Novo Nordisk, told FormularyWatch.
“This milestone establishes Ozempic as an option for adults to help address 2 critical aspects of managing type 2 diabetes: blood sugar control and cardiovascular risk reduction, in those with known heart disease,” he added.
CVD is the main cause of death and disability among people with type 2 diabetes and adults with type 2 diabetes are two to four times more likely to develop CVD than adults without diabetes, Novo Nordisk said in a statement.
FDA’s approval is based on the SUSTAIN 6 cardiovascular outcomes trial (CVOT), which found that Ozempic significantly reduced the risk of occurrence of a three-component MACE endpoint consisting of cardiovascular death, non-fatal heart attack or non-fatal stroke.
The estimated relative risk reduction of MACE was 26% for Ozempic versus placebo with the primary composite outcome occurring in 6.6% of patients treated with Ozempic® vs 8.9% with placebo.
Novo Nordisk was also allowed to add details to its semaglutide (Rybelsus) 7 mg. or 14 mg. prescribing information. It now include an analysis from the primary endpoint of the PIONEER 6 CVOT showing the hazard ratio for time to first 3-component MACE.
Last June, Novo Nordisk initiated the SOUL CVOT in 9,642 adults with type 2 diabetes and established cardiovascular disease to further evaluate the cardiovascular effect of Rybelsus. The ongoing trial is investigating the effects of Rybelsus on the incidence of MACE versus placebo in addition to standard of care.