The Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for empagliflozin (Jardiance; Boehringer Ingelheim and Lilly) to reduce the risk of cardiovascular death and hospitalization for heart failure and to slow kidney function decline in adults with chronic heart failure with reduced ejection fraction, including those with and without type 2 diabetes.
The sNDA is supported by data from the phase 3 EMPEROR-Reduced trial that compared the efficacy and safety of empagliflozin to placebo, in addition to recommended therapy, in 3730 patients with chronic heart failure with reduced ejection fraction. Results from the trial demonstrated that empagliflozin reduced the risk for heart failure hospitalization and slowed kidney function decline in patients with heart failure with markedly reduced ejection fraction, including those with concomitant diabetes.
The FDA previously granted Fast Track designation to empagliflozin for this indication. The sodium-glucose cotransporter 2 (SGLT2) inhibitor is also being investigated in the phase 3 EMPEROR-Preserved trial in patients with heart failure with preserved ejection fraction.
Jardiance, is currently approved to reduce the risk of cardiovascular (CV) death in adults with type 2 diabetes and established CV disease. It is also indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
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US FDA accepts supplemental New Drug Application for Jardiance® (empagliflozin) for adults with heart failure with reduced ejection fraction. [press release]. Ridgefield, CT and Indianapolis, IN: Boehringer Ingelheim and Eli Lilly and Company; January 11, 2021.