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).

 

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.

 

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.

 

“Jardiance was the first SGLT2 inhibitor to demonstrate cardiovascular protective effects and improve cardiovascular outcomes in patients with type 2 diabetes,” said Waheed Jamal, M.D., Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim. “We are delighted to now be able to offer Jardiance to people with heart failure with reduced ejection fraction, regardless of diabetes status. We look forward to collaborating with regulators in Europe and beyond to ensure access to this trusted therapy.”