Empagliflozin (Jardiance) Approved in Europe for Heart Failure with Reduced Ejection Fraction; Regulatory Submission Filed in China

On June 21, 2021, Boehringer Ingelheim and Eli Lilly and Company jointly announced that the European Commission approved the expanded indication for its SGLT2 inhibitor empagliflozin tablets (empagliflozin, English brand name Jardiance) for the treatment of patients with chronic heart failure with reduced ejection fraction (with or without type 2 diabetes).

A prior Phase 3 trial demonstrated that, compared with placebo, the drug reduced the composite relative risk of cardiovascular death or hospitalization by 25% in such patients. Notably, at the end of last year, the two companies also submitted a registration application to the China National Medical Products Administration (NMPA) for empagliflozin for the treatment of adult patients with heart failure with reduced ejection fraction (HFrEF), with or without diabetes.

Empagliflozin is a highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor for once-daily oral administration. In patients with type 2 diabetes and elevated blood glucose levels, it inhibits renal glucose reabsorption, thereby increasing urinary glucose excretion. Additionally, empagliflozin inhibits sodium reabsorption, which increases sodium excretion and reduces the fluid load within the vascular system. Through these induced metabolic changes in glucose, sodium, and water, it reduces the risk of cardiovascular death and major adverse cardiovascular events.

Cardio-renal-metabolic conditions affect over 1 billion people worldwide. These three systems are interconnected, and dysfunction in one system may accelerate disease progression in the others. For example, heart failure increases the risk of mortality in type 2 diabetes and kidney disease; therefore, improving one system can also yield positive effects on the others.

Heart failure is a very common and serious complication of heart attacks, with an incidence that increases with age. It occurs when the heart is unable to pump sufficient blood to the rest of the body. Patients frequently experience shortness of breath and fatigue, which significantly impairs their quality of life. Heart failure is classified into heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF). A reduced ejection fraction indicates that the heart cannot contract normally, whereas a preserved ejection fraction signifies that the heart cannot fill adequately.

This marketing authorization approval is based on the results of the randomized, double-blind phase 3 clinical trial, EMPEROR-Reduced. The trial enrolled a total of 3,730 patients. The trial met its primary endpoint, demonstrating a 25% relative risk reduction in the composite of cardiovascular death or hospitalization for heart failure compared with placebo, regardless of type 2 diabetes status. Furthermore, analysis of key secondary endpoints showed that empagliflozin reduced the relative risk of first and recurrent hospitalizations for heart failure by 30% and significantly slowed the decline in renal function.

Note: The original text has been abridged.

References:

[1] Jardiance (empagliflozin) approved in Europe for the treatment of heart failure with reduced ejection fraction. Retrieved June 21, 2021, from https://www.businesswire.com/news/home/20210621005298/en

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