Jardiance is EU approved for the treatment of heart failure with reduced ejection fraction – Boehringer + Eli Lilly

The European Commission has granted marketing authorization for Jardiance (empagliflozin) as a treatment for adults with symptomatic chronic heart failure with reduced ejection fraction (systolic heart failure), Boehringer Ingelheim and Eli Lilly and Company have announced. The extension of the indication follows a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) on 20 May 2021

“Today’s approval provides an important new treatment option which can now help the millions of people in Europe living with symptomatic chronic heart failure with reduced ejection fraction,” said Faiez Zannad, M.D., Ph.D., EMPEROR Program clinical investigator and Emeritus Professor of Therapeutics at the University of Lorraine, France. “New treatment options such as empagliflozin can save lives and help people spend less time in the hospital and more time with their families.”

Marketing authorization is based on results from the EMPEROR-Reduced trial in which empagliflozin showed a significant 25 percent reduction in the combined relative risk versus placebo of cardiovascular death or hospitalization due to heart failure. The findings from the primary endpoint were consistent in subgroups with or without type 2 diabetes. Key secondary endpoint analyses from the trial demonstrated that empagliflozin reduced the relative risk of first and recurrent hospitalization for heart failure by 30 percent and significantly slowed kidney function decline.