US FDA approves Jardiance (empagliflozin) to treat adults with heart failure regardless of left ventricular ejection fraction

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According to Boehringer Ingelheim and Eli Lilly and Company, the US Food and Drug Administration (FDA) has approved empagliflozin 10 mg to lower the risk of cardiovascular death and hospitalisation in individuals with heart failure.

Empagliflozin is not recommended for those with type 1 diabetes since it raises the risk of diabetic ketoacidosis. It is not for use to enhance glycemic control in individuals with type 2 diabetes who have an eGFR of less than 30 mL/min/1.73 m5, as its mechanism of action suggests it will be ineffective in this situation. Adults with heart failure who have an eGFR of less than 20 mL/min/1.73 m2 can start using empagliflozin. 5

“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. 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,”

said Javed Butler, M.D., chairman, Department of Medicine, University of Mississippi.

Heart failure, which affects more than 6 million individuals in the United States, is a primary cause of hospitalisation and is getting more common as the population ages. 3,6 Jardiance was licenced just six months ago to minimise the risk of cardiovascular death and hospitalisation in patients with heart failure with a reduced left ventricular ejection fraction (LVEF). The decision today broadens the scope of this indication to cover all individuals with heart failure. As a result, adults with maintained LVEF are now included in the indication.

Empagliflozin is contraindicated in those who have a hypersensitivity to empagliflozin or any of the excipients in Jardiance, as reactions such as angioedema have been reported, as well as in dialysis patients.

This approval is based on the results of the EMPEROR-Preserved® phase III study, which assessed the effects of empagliflozin 10 mg with placebo once daily, both on top of standard of care medication, in 5,988 individuals with heart failure and LVEF more than 40%. Jardiance showed a 21% relative risk reduction (3.3 percent absolute risk reduction, 0.79 HR, 0.69-0.90 95 percent CI) in the trial for the composite primary outcome of cardiovascular death or heart failure hospitalisation. 7 The advantage was consistent across LVEF subgroups in both EMPEROR-Preserved and EMPEROR-Reduced. 7,8

Jardiance reduced the relative risk of first and recurrent heart failure hospitalizations by 27%, according to a crucial secondary endpoint study from EMPEROR-Preserved (407 events for Jardiance vs. 541 for placebo, 0.73 HR, 0.61-0.88 95 percent CI). 8

“The FDA approval is very welcome news for people living with heart failure in the U.S. We now look forward to further approvals globally to bring empagliflozin treatment to many more heart failure patients, across the range of their left ventricular ejection fraction. The significant clinical benefits seen in the EMPEROR-Preserved clinical trial gives clinicians an opportunity to redefine the way we approach the treatment of heart failure and is a significant step forward in this area of unmet need for patients,”

said Waheed Jamal, M.D., Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim. 

“This approval reinforces the potential of Jardiance as a crucial treatment option to help fill an urgent need for adults across the full spectrum of heart failure. Building on the indication for heart failure with reduced ejection fraction last year, this decision marks the third U.S. FDA approval for empagliflozin stemming from the EMPOWER program and adds to a growing legacy of leadership for the Boehringer Ingelheim and Lilly Alliance spanning cardiovascular disease and type 2 diabetes,”

said Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly.
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