Date: 18-Sep-2020

Boehringer Ingelheim, Eli Lillys Jardiance Receive US FDA Fast Track Status To Improve Outcomes Following A Heart Attack

Boehringer Ingelheim and Eli Lilly and Company announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of Jardiance (empagliflozin) 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 (more commonly known as a heart attack).

More than 1.5 million heart attacks, which are the leading cause of heart failure and are associated with a high risk of death, occur annually in the US. A heart attack occurs as a result of reduced blood flow to part of the heart muscle.

“Ischemic heart disease (IHD) is the leading cause of death and disability in the US 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, M.D., M.P.H., M.H.A., vice president, clinical development & medical affairs, cardio-metabolism & respiratory medicine, Boehringer Ingelheim Pharmaceuticals. “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.”
 
EMPACT-MI (A Streamlined, Multicenter, Randomized, Parallel Group, Double-blind Placebo-controlled Superiority Trial to Evaluate the Effect of EMPAgliflozin on Hospitalization for Heart Failure and Mortality in Patients With aCuTe Myocardial Infarction) 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 programme, the broadest and most comprehensive clinical program for an SGLT2 inhibitor. EMPOWER explores the impact of Jardiance on the lives of people across the spectrum of cardio-renal-metabolic conditions.
 
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. Jardiance is contraindicated in patients with a history of serious hypersensitivity reaction to empagliflozin or any of the excipients of Jardiance, and in patients with severe renal impairment, end-stage renal disease, or dialysis. Jardiance is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
 
“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, M.D., Ph.D., vice president, Product Development, Lilly. “We remain committed to finding breakthrough outcomes for people with and without type 2 diabetes, including the prevention and treatment of heart failure. We look forward to learning the results of EMPACT-MI, which are anticipated in 2023.”

The Alliance has developed the EMPOWER program to explore the impact of Jardiance on major clinical cardiovascular and renal outcomes in a spectrum of cardio-renal-metabolic conditions. Cardio-renal-metabolic conditions are the leading cause of mortality worldwide and account for up to 20 million deaths annually. Through the EMPOWER programme, Boehringer Ingelheim and Lilly are working to advance knowledge of these interconnected systems and create care which offers integrated, multi-organ benefits. Comprised of eight clinical trials and two real-world evidence studies, EMPOWER reinforces the long-term commitment of the Alliance to improve outcomes for people living with cardio-renal-metabolic conditions. With more than 257,000 adults studied worldwide in clinical studies, it is the broadest and most comprehensive clinical program for an SGLT2 inhibitor to date.