The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Jardiance® (empagliflozin) which is being investigated as a potential new treatment 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, Boehringer Ingelheim and Eli Lilly and Company announced. A high unmet need remains in the treatment of heart failure, as approximately half of all those diagnosed are expected to die within five years. Heart failure is also the leading cause of hospitalization in the U.S., with an estimated one million people being hospitalized due to the condition each year. The risk of death in people with heart failure rises with each hospital admission. Heart failure with reduced ejection fraction occurs when the heart muscle does not contract effectively, and less blood is pumped out to the body compared to a normally functioning heart. The sNDA is based on results from the EMPEROR-Reduced phase III trial, in which Jardiance was associated with a significant 25% relative risk reduction in the primary composite endpoint of time to cardiovascular death or hospitalization due to heart failure. Additionally, the rate of decline in eGFR, a measure of kidney function decline, was slower with Jardiance than with placebo, when both were given on top of standard of care treatment. Results were published in The New England Journal of Medicine in August 2020. Initially approved in 2014, Jardiance is a once-daily tablet used along with diet and exercise to lower blood sugar in adults with type 2 diabetes and to reduce the risk of cardiovascular death in adults with type 2 diabetes and known cardiovascular disease. Jardiance is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine). Jardiance is contraindicated in people with a history of serious hypersensitivity reaction to empagliflozin or any of the excipients of Jardiance, and in people with severe renal impairment, end-stage renal disease, or dialysis. The FDA previously granted Fast Track designation to Jardiance for the reduction of the risk of cardiovascular death and hospitalization for heart failure in people with heart failure. This designation is for the EMPEROR program, which consists of the EMPEROR-Reduced and EMPEROR-Preserved trials. EMPEROR-Preserved is exploring the effect of Jardiance on cardiovascular death or hospitalization for heart failure in adults with heart failure with preserved ejection fraction. EMPEROR-Preserved results are expected in 2021. Jardiance is not indicated for the treatment of heart failure with reduced or preserved ejection fraction, to reduce hospitalization for heart failure, or to slow kidney function decline. In March 2020, the FDA has also granted Fast Track designation to Jardiance for the treatment of chronic kidney disease. This designation covers the ongoing EMPA-KIDNEY trial, the results of which are expected in 2022. Jardiance is not indicated for the treatment of chronic kidney disease. The EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure) heart failure studies are two phase III, randomized, double-blind trials investigating once-daily Jardiance compared with placebo in adults with heart failure with preserved or reduced ejection fraction, both with and without diabetes, who are receiving current standard of care: EMPEROR-Reduced [NCT03057977 [1]] investigated the safety and efficacy of Jardiance in patients with chronic heart failure with reduced ejection fraction (HFrEF). Primary composite endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure. Number of patients: 3,730. Completion: 2020. EMPEROR-Preserved[NCT03057951 [2]] investigates the safety and efficacy of Jardiance in patients with chronic heart failure with preserved ejection fraction (HFpEF). Primary composite endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure [Time Frame: up to 38 months]. Anticipated number of patients: approx. 5,990. Estimated completion: 2021. Ejection fraction is a measurement of the percentage of blood the left ventricle pumps out with each contraction. When the heart relaxes, the ventricle refills with blood. HFrEF occurs when the heart muscle does not contract effectively, and less blood is pumped out to the body compared with a normally functioning heart. HFpEF occurs when the heart muscle contracts normally but the ventricle does not fill with enough blood, so less blood can enter the heart compared with a normally functioning heart.