Boehringer Ingelheim and Eli Lilly’s Jardiance Approved by FDA to Treat Adults With Heart Failure Regardless of LVEF

February 25, 2022 – Boehringer Ingelheim and Eli Lilly and Company announced that FDA has approved the companies’ Jardiance (empagliflozin) 10 mg to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure.

According to the companies, empagliflozin can be initiated in adults with heart failure with an estimated glomerular filtration rate (eGFR) as low as 20 mL/min/1.73 m². The approval is based on results from the EMPEROR-Preserved phase 3 trial, which investigated the effect of empagliflozin 10 mg compared with placebo once daily, both on top of standard-of-care therapy, in 5,988 adults with heart failure with left ventricular ejection fraction (LVEF) > 40%.

In the EMPEROR-Preserved trial, empagliflozin demonstrated a 21% relative risk reduction (absolute risk reduction, 3.3%; hazard ratio, 0.79; 95% CI, 0.69-0.90) for the composite primary endpoint of cardiovascular death or hospitalization for heart failure.

A key secondary endpoint analysis from EMPEROR-Preserved showed that empagliflozin reduced the relative risk of first and recurrent hospitalizations for heart failure by 27% (407 events for empagliflozin versus 541 for placebo; hazard ratio, 0.73; CI 95%, 0.61-0.88).

The EMPEROR-Preserved results were presented at the European Society of Cardiology Congress 2021 held virtually August 27-30, 2021. The study was published by Principal Investigator Stefan D. Anker, MD, et al in The New England Journal of Medicine (2021;385:1451-1461).

In August 2021, the companies announced that Jardiance was approved to reduce the risk of cardiovascular death plus hospitalization for heart failure with reduced LVEF. The approval was supported by findings from the EMPEROR-Reduced phase 3 trial.

In both EMPEROR-Preserved and EMPEROR-Reduced, the benefit was generally consistent across LVEF subgroups, noted the companies.

The latest approval expands this indication to include all adults with heart failure. As a result, the indication now includes adults with preserved LVEF.

“In its phase 3 trials, empagliflozin has shown a statistically significant and clinically meaningful benefit in patients with heart failure across the spectrum of ejection fraction,” commented Javed Butler, MD, in the companies’ press release. “Today’s approval means these demonstrated benefits can now help to address a significant unmet need for the approximately 3 million adults in the United States with preserved ejection fraction, a form of heart failure that has very limited treatment options.” Dr. Butler is Chairman of the Department of Medicine at University of Mississippi in Jackson, Mississippi.

The companies advised that empagliflozin is not for patients with type 1 diabetes because 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 because it is likely to be ineffective in this setting based on its mechanism of action.

Additionally, empagliflozin is contraindicated in people with hypersensitivity to empagliflozin or any of the excipients in Jardiance, as reactions such as angioedema have occurred, and in patients on dialysis.