– The EMPEROR-Preserved phase III trial met its primary endpoint and demonstrated significant risk reduction with Jardiance for the composite of cardiovascular death or hospitalization for heart failure in adults with heart failure with preserved ejection fraction
– Heart failure with preserved ejection fraction has been classified as “the single largest unmet need in cardiovascular medicine”¹ based on prevalence, poor outcomes and absence of clinically proven therapies to date
– With approval, Jardiance would become the first and only clinically proven therapy to improve outcomes for the full spectrum of heart failure patients regardless of ejection fraction
RIDGEFIELD, Conn. and INDIANAPOLIS, July 6, 2021 /PRNewswire/ — The EMPEROR-Preserved phase III trial met its primary endpoint, establishing Jardiance® (empagliflozin) as the first and only therapy to significantly reduce the risk of the composite of cardiovascular death or hospitalization for heart failure in adults, with or without diabetes, who live with heart failure with preserved ejection fraction (HFpEF). Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced the topline results today. When added to the EMPEROR-Reduced trial results, these findings demonstrate Jardiance’s efficacy in all forms of heart failure regardless of ejection fraction. The safety profile was generally consistent with the known safety profile of Jardiance.
“We look forward to presenting the EMPEROR-Preserved results at ESC 2021, which should offer a significant breakthrough in cardiovascular medicine and a new hope for people with HFpEF, which is an increasingly prevalent public health issue. HFpEF has long been the most challenging form of heart failure to treat,” said Professor Stefan Anker, heart failure cardiologist at Charité Berlin, Germany, and EMPEROR-Preserved principal investigator. “Building on previous results from the EMPA-REG OUTCOME trial, and the EMPEROR-Reduced trial in heart failure with reduced ejection fraction, the EMPEROR-Preserved findings demonstrate that empagliflozin reduces cardiovascular death or hospitalization for heart failure and has the potential to transform the care of people living with heart failure.”
Heart failure poses a significant global disease burden: more than 60 million patients worldwide have heart failure, and half of them have HFpEF. Heart failure is a leading cause of hospitalization and is becoming increasingly prevalent in Western countries due to aging populations. The risk of death in people with heart failure rises with each hospital admission. Heart failure with left ventricular preserved ejection fraction occurs when the left ventricle of the heart is unable to fill properly, resulting in less blood being pumped to the body.
“No approved therapies have been clinically proven to improve outcomes specifically for people with HFpEF, leaving a significant unmet medical need in this already prevalent and increasingly common form of heart failure,” said Mohamed Eid, M.D., M.P.H., M.H.A., vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. “The totality of the data from the EMPEROR-Preserved trial marks a possible new chapter in heart failure, supporting the potential of Jardiance to become the first SGLT2 inhibitor to treat a defined population of adults with heart failure with either preserved or reduced ejection fraction.”
“Jardiance was the first SGLT2 inhibitor to reduce cardiovascular death for people with type 2 diabetes and cardiovascular disease, and we have now reached another important milestone, this time in heart failure,” added Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly. “The EMPEROR-Preserved results offer promise in a type of heart failure that until now has traditionally been very challenging to treat effectively. The EMPEROR heart failure studies are part of our EMPOWER clinical trial program exploring the effect of Jardiance across a spectrum of cardio-renal-metabolic diseases, aiming to significantly improve outcomes in these highly prevalent conditions that impact many people’s lives.”
The EMPEROR-Preserved trial investigated Jardiance 10 mg compared with placebo. Full results from the EMPEROR-Preserved trial are scheduled for presentation at the European Society of Cardiology (ESC) Congress 2021 on August 27. Boehringer Ingelheim and Lilly plan for regulatory submissions in 2021.
These results add to previous findings from the EMPEROR-Reduced phase III trial, which showed that Jardiance significantly reduced the combined relative risk of cardiovascular death or hospitalization for heart failure by 25% compared to placebo in adults with heart failure with reduced ejection fraction (HFrEF). Together, these studies demonstrate the benefits of Jardiance for patients across the full heart failure spectrum (including HFrEF and HFpEF).
The EMPEROR-Reduced results formed the basis of the recent approval of a new indication for Jardiance for the treatment of adults with HFrEF by the European Commission. In the U.S., Jardiance is not approved for the treatment of heart failure. A supplemental New Drug Application (sNDA) for Jardiance to reduce the risk of cardiovascular death or hospitalization for heart failure in adults with HFrEF has been submitted to the U.S. Food and Drug Administration (FDA), with a decision expected later this year. Research is ongoing regarding Jardiance’s effects on hospitalization for heart failure and mortality in post-myocardial infarction (heart attack) patients with high risk of heart failure. Jardiance is also currently being investigated in chronic kidney disease.
¹ Butler J, Fonarow G, Zile M, et al. Developing therapies for heart failure with preserved ejection fraction: Current State and Future Directions. JACC Heart Fail. 2014 Apr;2(2):97–112.
SOURCE Eli Lilly and Company