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2021 | HFSA

US FDA approves Jardiance® (empagliflozin) to treat adults living with heart failure with reduced ejection fraction

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Ridgefield, Conn. and Indianapolis, August 18, 2021 – Jardiance® (empagliflozin) 10 mg has been approved by the U.S. Food and Drug Administration to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure with reduced ejection fraction (HFrEF), 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 <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 HFrEF with an eGFR as low as 20 mL/min/1.73 m2.

“Heart failure is a chronic, debilitating cardio-renal-metabolic condition affecting over 60 million people worldwide. As the prevalence of heart failure continues to rise, the need for new treatment options is critical,” said Javed Butler, M.D., Chairman, Department of Medicine, University of Mississippi. “Empagliflozin is a vital new therapeutic option to reduce the risk of cardiovascular death and hospitalization for adults with heart failure with reduced ejection fraction.”

HFrEF, which accounts for more than half of heart failure cases, occurs when the heart muscle does not contract effectively, and less blood is pumped out to the body compared with a normally functioning heart.

This approval for Jardiance is based on results from the EMPEROR-Reduced phase III trial, which investigated the effect of adding Jardiance 10 mg versus placebo to standard of care in a broad range of 3,730 adults with and without type 2 diabetes who had heart failure (functional class II, III or IV) and a left ventricular ejection fraction of 40% or less. In the trial, Jardiance significantly reduced the relative risk of the primary composite endpoint of time to cardiovascular death or hospitalization for heart failure by 25% (5.3% absolute risk reduction, 0.75 HR, 0.65-0.86 95% CI) versus placebo. These results were seen regardless of background heart failure standard of care treatments.