The FDA designation enables development of Jardiance to prevent hospitalisation for heart failure and minimise the risk of death in patients who had heart attack
Boehringer Ingelheim and Eli Lilly and Company (Lilly) have secured the US Food and Drug Administration (FDA) Fast Track designation for Jardiance (empagliflozin) to improve outcomes after a heart attack.
The FDA designation enables the development of Jardiance to prevent hospitalisation for heart failure and minimise the risk of death in patients who have had an acute myocardial infarction (heart attack), regardless of having diabetes.
Boehringer Ingelheim and Lilly have initially collaborated in January 2011, focused on developing compounds representing different diabetes treatment classes. The alliance has initiated clinical trials to evaluate Jardiance in people with heart failure or chronic kidney disease.
Boehringer Ingelheim Pharmaceuticals cardio-metabolism and respiratory medicine clinical development and medical affairs vice president Mohamed Eid said: “Ischemic heart disease (IHD) 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.
“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 and Boehringer Ingelheim are evaluating Jardiance in EMPOWER programme
Jardiance is a once-daily medication, taken along with diet and exercise to reduce blood sugar in adults with type 2 diabetes along with the risk of cardiovascular death in adults with type 2 diabetes and known cardiovascular disease.
The drug is not indicated for 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. Also, the drug is not for people with type 1 diabetes or diabetic ketoacidosis.
The companies have developed the EMPOWER programme to evaluate the effect of Jardiance on major cardiovascular and renal outcomes across various cardio-renal-metabolic conditions.
The clinical trial programme is comprised of eight clinical trials and two real-world evidence studies and is aimed at improving outcomes for people living with cardio-renal-metabolic conditions.
A part of the EMPOWER programme, EMPACT-MI is evaluating Jardiance to improve mortality and hospitalisation 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.
Boehringer Ingelheim and Lilly are offering to fund for the Phase 3 clinical trial and is being conducted, analysed and reported in partnership with the Duke Clinical Research Institute (DCRI).
Lilly product development vice president Jeff Emmick said: “The FDA Fast Track designation for Jardiance is an important milestone towards addressing an unmet need for people who have had a heart attack.
“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.”