FDA Grants Fast Track Designation to Lilly Drug
Indianapolis-based Eli Lilly and Co. (NYSE: LLY) and Germany-based Boehringer Ingelheim Pharmaceuticals Inc. are getting a Fast Track designation from the U.S. Food and Drug Administration for another use of the drug Jardiance. Lilly says the drug helps prevent hospitalization for heart failure and reduce the risk of mortality in patients, with and without diabetes, who have had a heart attack.
Jardiance was originally developed to lower blood sugar in adults with type 2 diabetes and its also used to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease.
Lilly says more than 1.5 million heart attacks occur annually in the U.S.
“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 Dr. Jeff Emmick, vice president of product development at Lilly. “We remain committed to finding breakthrough outcomes for people with and without type 2 diabetes, including the prevention and treatment of heart failure.”
The companies are currently conducting a clinical trial to investigate 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 without a history of chronic heart failure.
“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 IHD, and treatment options are urgently needed to help improve outcomes,” said Dr. Mohamed Eid, vice president of clinical development & medical affairs at Boehringer Ingelheim. “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.”
Lilly says the randomized clinical trial is being conducted, analyzed and reported in partnership with the Duke Clinical Research Institute.