CHMP issues positive opinion for Jardiance for the treatment of adults with heart failure with reduced ejection fraction. - Boehringer + Eli Lilly.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending Jardiance (empagliflozin) for the treatment of adults with symptomatic chronic heart failure with reduced ejection fraction (HFrEF), Boehringer Ingelheim and Eli Lilly and Company announced “Heart failure is a progressive and debilitating condition affecting 60 million people worldwide. It is the leading cause of hospitalizations in Europe – not only impacting the quality of life considerably for those living with the condition but also putting significant pressure on healthcare systems,” said Faiez Zannad, M.D., Ph.D., EMPEROR Program clinical investigator and Emeritus Professor of Therapeutics at the University of Lorraine, France. “If Marketing Authorisation is granted by the European Commission, empagliflozin will provide an important additional treatment option for the millions of people in Europe already living with symptomatic chronic heart failure with reduced ejection fraction.” The positive opinion is based on results from the EMPEROR-Reduced trial in which empagliflozin showed a significant 25 percent reduction in the combined relative risk of cardiovascular death or hospitalization due to heart failure. The findings from the primary endpoint were consistent in subgroups with and 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.