FDA fast-tracks empagliflozin for improving patient outcomes following a heart attack

Boehringer Ingelheim and Eli Lilly and Company announced Tuesday, Sept. 15, that the FDA has granted a a Fast Track designation for the development of empagliflozin to improve patient outcomes following an acute myocardial infarction (ACI). The designation covers both patients with and without diabetes.

Empagliflozin, sold under the name Jardiance, is used to lower blood sugar in patients with type 2 diabetes. It is also prescribed to help reduce the risk of cardiovascular death in patients with type 2 diabetes and known cardiovascular disease.

“Ischemic heart disease (IHD) is the leading cause of death and disability in the U.S.,” Mohamed Eid, MD, MPH, MHA, vice president of clinical development and medical affairs for Boehringer Ingelheim’s cardio-metabolism and respiratory medicine division, said in a statement. “Myocardial infarction, or heart attack, is the deadliest acute manifestation of IHD, and treatment options are urgently needed to help improve outcomes.”

“The FDA Fast Track designation for Jardiance is an important milestone towards addressing an unmet need for people who have had a heart attack,” Jeff Emmick, MD., PhD, vice president of product development for Lilly, said in the same statement. “We remain committed to finding breakthrough outcomes for people with and without type 2 diabetes, including the prevention and treatment of heart failure.”

The EMPACT-MI trial is currently underway, with Boehringer Ingelheim and Lilly investigating the effect of empagliflozin on ACI patients.