The US Food and Drug Administration (FDA) has approved Boehringer Ingelheim and Eli Lilly and Company’s Jardiance (empagliflozin) to treat Heart Failure with reduced Ejection Fraction (HFrEF).
Jardiance is a prescription medicine, which is used along with diet and exercise, to reduce blood sugar levels in adults with type 2 diabetes and the risk of cardiovascular death in adults with type 2 diabetes.
Eli Lilly stated that HFrEF, which occurs when the heart muscle does not contract effectively and causes less blood flow to the body, accounts for more than half of heart failure cases.
The FDA approval is based on the data obtained from the EMPEROR-Reduced phase III trial, which was performed on 3,730 HFrEF patients with and without type 2 diabetes.
This study showed that Jardiance reduced the risk of primary composite endpoint of time to cardiovascular death or hospitalisation by 25% against placebo.
The drug has also reduced the risk of first and recurrent hospitalisation for heart failure by 30% and retained its safety profile.
Boehringer Ingelheim Cardio-Metabolism & Respiratory Medicine Clinical Development & Medical Affairs vice president Mohamed Eid said: “Around half of all people with heart failure, unfortunately, are expected to die within five years of diagnosis. The risk of death increases with each hospitalization for heart failure.
“In the EMPEROR-Reduced trial, Jardiance protected a broad range of adults with heart failure with reduced ejection fraction by reducing risk of cardiovascular death and hospitalization for heart failure, regardless of their baseline heart failure medications or type 2 diabetes status, when added to standard of care.”
Eli Lilly noted that the drug is not for people with type 1 diabetes as it may increase their risk of diabetic ketoacidosis.
It is also not intended for use to reduce blood sugar in type 2 diabetes patients with severe kidney problems.