FDA OKs Fast Track for Empagliflozin in Heart Failure, Acute MI Patients

The manufacturers of Jardiance (empagliflozin) accounted that the FDA has granted FastTrack status to the drug for the improvement of patients suffering from heart failure and myocardial infarction.

“Ischemic heart disease is the leading cause of death and disability in the U.S. Myocardial infarction, or heart attack, is the deadliest acute manifestation of ischemic heart disease, and treatment options are urgently needed to help improve outcomes,” Mohamed Eid, MD, MPH, MHA, vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc., said in a press release. “We look forward to working closely with the FDA as we explore the potential for Jardiance to improve survival and prevent hospitalization for heart failure for adults who have had a heart attack, through our EMPACT-MI trial.”

The EMPACT-MI study was a multicenter parallel-group randomized double-blind placebo controlled trial looking at the effect of empagliflozin on hospitalization for heart failure and also mortality in patients (both with and without type 2 diabetes) who have experienced an acute myocardial infarction. The phase III study is currently being conducted in conjunction with the Duke Clinical Research Institute (funded by Boehringer Ingelheim and Lilly). The study is part of the EMPOWER clinical trial program, looking at the impact of empagliflozin in a variety of patient populations and with many different cardio-renal-metabolic conditions.

“The FDA Fast Track designation for Jardiance is an important milestone towards addressing an unmet need for people who have had a heart attack,” said Jeff Emmick, MD, PhD, Vice President of Product Development at Lilly, said.

Results of the study are anticipated in 2023. To read more DocWire News coverage of empagliflozin, click here.