Ridgefield, Conn. and INDIANAPOLIS, February 24, 2022 – The U.S. Food and Drug Administration (FDA) has approved Jardiance® (empagliflozin) 10 mg to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced today.
Jardiance is not for people with type 1 diabetes as it may increase the risk of diabetic ketoacidosis in these patients. It is not for use to improve glycemic control in adults with type 2 diabetes with an eGFR below 30 mL/min/1.73 m2 as it is likely to be ineffective in this setting based upon its mechanism of action.
Jardiance can be initiated in adults with heart failure with an eGFR as low as 20 mL/min/1.73 m2.
“In its phase III trials, empagliflozin has shown a statistically significant and clinically meaningful benefit in patients with heart failure across the spectrum of ejection fraction,” said Javed Butler, M.D., chairman, Department of Medicine, University of Mississippi. “Today’s approval means these demonstrated benefits can now help to address a significant unmet need for the approximately 3 million adults in the U.S. with preserved ejection fraction, a form of heart failure that has very limited treatment options.”
Affecting more than 6 million people in the U.S., heart failure is a leading cause of hospitalization and is becoming increasingly prevalent due to the aging population. Just six months ago, Jardiance was approved to reduce the risk of cardiovascular death plus hospitalization for one type of heart failure – heart failure with reduced left ventricular ejection fraction (LVEF). Today’s decision expands this indication to adults with heart failure. As a result, the indication now includes adults with preserved LVEF.