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Eli Lilly, Boehringer Ingelheim: FDA Grants Fast Track Designation To Jardiance

Boehringer Ingelheim and Eli Lilly and Co. (LLY) said Tuesday that the U.S. Food and Drug Administration or FDA has granted Fast Track designation for the development of Jardiance (empagliflozin) to prevent hospitalization for heart failure and reduce the risk of mortality following an acute myocardial infarction in patients with and without diabetes.

Acute myocardial infarction, more commonly known as a heart attack, is the leading cause of heart failure and is associated with a high risk of death. More than 1.5 million heart attacks occur annually in the U.S.

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.

"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," said Mohamed Eid, vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc.

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 myocardial infarction and no history of chronic heart failure.

This randomized clinical phase III trial is being conducted, analyzed and reported in partnership with the Duke Clinical Research Institute (DCRI), with Boehringer Ingelheim and Lilly providing funding.

EMPACT-MI is part of the EMPOWER clinical program, the broadest and most comprehensive clinical program for an SGLT2 inhibitor.

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