US FDA approves Jardiance to treat adults living with heart failure with reduced ejection fraction

Jardiance 10 mg has been approved by the US Food and Drug Administration (FDA) to reduce the risk of cardiovascular death plus hospitalisation for heart failure in adults with heart failure with reduced ejection fraction (HFrEF), Boehringer Ingelheim and Eli Lilly and Company announced recently in a statement.

Jardiance is not for people with type-1 diabetes as it may increase the risk of diabetic ketoacidosis in these patients. It is not for use to improve glycemic control in adults with type-2 diabetes with an eGFR <30 mL/min/1.73 m2 as it is likely to be ineffective in this setting based upon its mechanism of action.

Jardiance can be initiated in adults with HFrEF with an eGFR as low as 20 mL/min/1.73 m2.

“Heart failure is a chronic, debilitating cardio-renal-metabolic condition affecting over 60 million people worldwide. As the prevalence of heart failure continues to rise, the need for new treatment options is critical,” said Javed Butler, MD, Chairman, Department of Medicine, University of Mississippi.

He added, “Empagliflozin is a vital new therapeutic option to reduce the risk of cardiovascular death and hospitalisation for adults with heart failure with reduced ejection fraction.”

HFrEF, which accounts for more than half of heart failure cases, occurs when the heart muscle does not contract effectively, and less blood is pumped out to the body compared with a normally functioning heart.

This approval for Jardiance is based on results from the EMPEROR-Reduced phase-III trial, which investigated the effect of adding Jardiance 10 mg versus placebo to the standard of care in a broad range of 3,730 adults with and without type-2 diabetes who had heart failure (functional class II, III or IV) and a left ventricular ejection fraction of 40 per cent or less. In the trial, Jardiance significantly reduced the relative risk of the primary composite endpoint of time to cardiovascular death or hospitalisation for heart failure by 25 per cent (5.3 per cent absolute risk reduction, 0.75 HR, 0.65-0.86 95 per cent CI) versus placebo. These results were seen regardless of background heart failure standard of care treatments.

A key secondary endpoint analysis from EMPEROR-Reduced demonstrated that Jardiance helped keep patients out of the hospital by significantly reducing the relative risk of first and recurrent hospitalisation for heart failure by 30 per cent (388 events for Jardiance vs 553 for placebo, 0.70 HR, 0.58-0.85 95 per cent CI). The safety profile was consistent with the well-established safety profile of Jardiance.

“Around half of all people with heart failure, unfortunately, are expected to die within five years of diagnosis. The risk of death increases with each hospitalisation for heart failure,” said Mohamed Eid, MD, MPH, MHA, Vice President, Clinical Development and Medical Affairs, Cardio-Metabolism and Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals.

He also added, “In the EMPEROR-Reduced trial, Jardiance protected a broad range of adults with heart failure with reduced ejection fraction by reducing the risk of cardiovascular death and hospitalisation for heart failure, regardless of their baseline heart failure medications or type-2 diabetes status, when added to standard of care. The FDA approval of Jardiance in heart failure with reduced ejection fraction, which follows authorisation for use in the EU by the European Commission in June, marks an important milestone in our journey to help transform care for adults with heart failure. We look forward to continuing to investigate the potential benefit of Jardiance across cardio-renal-metabolic conditions.”