The top-selling diabetes drug will join semaglutide (Ozempic), which is approved to reduce the risk of major adverse cardiovascular events.
FDA granted Fast Track designation to Boehringer Ingelheim and Eli Lilly and Company to develop a new heart attack-related indication for the popular diabetes medication empagliflozin (Jardiance).
The indication will be to prevent hospitalization for heart failure and reduce the risk of mortality in patients, with and without diabetes, who have had a heart attack.
In January, FDA also 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.
“Ischemic heart disease (IHD) is the leading cause of death and disability in the U.S. Myocardial infarction, or heart attack, is the deadliest acute manifestation of IHD, and treatment options are urgently needed to help improve outcomes,” said Mohamed Eid, MD, vice president of Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine at Boehringer Ingelheim, in a press release.
Jardiance, a once-daily tablet, is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes and to reduce the risk of cardiovascular death in adults with type 2 diabetes and known cardiovascular disease.
The pharma makers will conduct the EMPACT-MI multi-center, double-blind placebo-controlled superiority trial to investigate the effect of Jardiance on all-cause mortality and hospitalization for heart failure in adults with and without type 2 diabetes who have had an acute myocardial infarction and no history of chronic heart failure.
The results of the EMPACT-MI Phase 3 clinical trial are expected in 2023.
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