FDA accepts supplemental NDA for Jardiance for adults with heart failure with reduced ejection fraction.- Eli Lilly + Boehringer

The 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.