Posted by Michael Wonder on 11 Jan 2021
US FDA accepts supplemental new drug application for Jardiance (empagliflozin) for adults with heart failure with reduced ejection fraction
11 January 2021 - The U.S. FDA has accepted a supplemental new drug application for Jardiance (empagliflozin) which is being investigated as a potential new treatment to reduce the risk of cardiovascular death and hospitalisation 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 announced.
The supplemental new drug application is based on results from the EMPEROR-Reduced Phase 3 trial, in which Jardiance was associated with a significant 25% relative risk reduction in the primary composite endpoint of time to cardiovascular death or hospitalisation due to heart failure.
