September 15, 2020
FDA Grants Fast Track Designation for Jardiance to Prevent Heart Failure in Patients After Acute MI
September 15, 2020—Boehringer Ingelheim and Eli Lilly and Company jointly announced that the FDA has granted Fast Track designation for the development of Jardiance (empagliflozin, an SGLT2 inhibitor) to prevent hospitalization for heart failure and reduce the risk of mortality in patients, with and without diabetes, who have had an acute myocardial infarction (MI).
Currently, Jardiance is a once-daily tablet 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 companies advised that the EMPACT-MI trial is investigating 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 MI and no history of chronic heart failure. It is a randomized clinical phase III trial being conducted, analyzed, and reported in partnership with the Duke Clinical Research Institute in Durham, North Carolina.
Boehringer Ingelheim and Eli Lilly are funding the EMPACT-MI trial, which is part of the EMPOWER clinical program that is evaluating the impact of Jardiance on patients in a spectrum of cardio-renal-metabolic conditions. The program includes eight clinical trials and two real-world evidence studies, noted the companies.