Boehringer Ingelheim and Eli Lilly and Company announced that the EMPEROR-Reduced Phase III trial in adults with heart failure with reduced ejection fraction, with and without diabetes, met the primary endpoint. Jardiance (empagliflozin) was superior to placebo in decreasing the risk of a composite of cardiovascular death or hospitalization from heart failure when added to standard of care.
In the U.S., heart failure is the leading cause of hospitalization. The risk of death in heart failure patients increases each time they are admitted to the hospital. Heart failure with reduced ejection fraction is when the heart muscle doesn’t contract effectively, resulting in less blood being pumped out to the body compared to a normally functioning heart.
“Heart failure is a common, but very serious chronic cardiovascular disorder, and it causes substantial disability while threatening the lives of millions of people worldwide,” said Milton Packer, chair of the executive committee for the EMPEROR Program and Distinguished Scholar in Cardiovascular Science at Baylor University Medical Center in Dallas. “The results of the EMPEROR-Reduced trial indicate that SGLT2 inhibitors have the potential to become a new standard of care for this disease, which will be a meaningful addition to currently established treatments.”
The companies plan to present the full results of the trial in a hot line session of the European Society of Cardiology (ESC) Congress 2020 on August 29. They also expect to make regulatory submissions for this indication this year.
In addition, they are conducting a second trial, EMPEROR-Preserved, to evaluate Jardiance on cardiovascular death or hospitalization in adults with heart failure with preserved ejection fraction, where there are no current approved treatment options. Results of that trial are expected next year.
The EMPEROR heart failure trials are two Phase III studies evaluating once-daily Jardiance compared to placebo in adults with heart failure with preserved or reduced ejection fraction, both with and without diabetes, who are receiving standard of care. Ejection fraction is a measurement of the percentage of blood the left ventricle pumps out with each contraction. When the heart relaxes, blood refills into the ventricle. HFrEF is when the heart muscle fails to contract effectively, and less blood is pumped to the body. HFpEF is when the heart muscle contracts normally, but the ventricle doesn’t fill with enough blood. This causes less blood to enter the heart.
In March of this year, the U.S. Food and Drug Administration (FDA) issued a complete response letter, turning down the companies’ application for the 2.5-milligram dose of Jardiance with insulin to treat Type 1 diabetes. This came after a November 2019 FDA advisory committee voted 14 to 2 against the drug based on lack of clinical data.
Jardiance is indicated with diet and exercise to lower blood sugar in adults with type 2 diabetes. It has also demonstrated that it reduces the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease.
“These results build upon the already established cardiovascular benefits of Jardiance in adults living with type 2 diabetes and cardiovascular disease,” said Jeff Emmick, vice president, Product Development, Lilly. “Metabolic conditions that affect the heart and kidneys can lead to serious consequences, including hospitalizations and death. Through our EMPOWER clinical program, we are committed to advancing knowledge about these devastating clinical outcomes. We look forward to seeing how Jardiance can help adults around the world living with these conditions.”