Boehringer Ingelheim/Eli Lilly’s Empagliflozin (Jardiance®) New Indication for Heart Failure Granted Priority Review in China

On March 2, the CDE website showed that the new indication application for empagliflozin tablets (Jardiance®) by Boehringer Ingelheim/Eli Lilly and Company, aimed at reducing the risk of cardiovascular death or hospitalization due to heart failure in adult patients with heart failure, is proposed to be included in the priority review and approval process, which is expected to accelerate its market entry.

According to the Insight database, this marketing application was accepted by the CDE on November 17, 2021, and is currently under review as a new submission task.

Source: CDE Official Website

Heart failure is a complex clinical syndrome caused by abnormal changes in the structure and/or function of the heart due to various reasons, leading to impaired systolic and/or diastolic function of the ventricles. It is a common and serious chronic disease that cannot be cured. Heart failure represents the severe manifestation and end stage of various heart diseases, with a rehospitalization rate as high as 24.5% and a mortality rate after diagnosis that almost rivals common malignant tumors, making it one of the most dangerous cardiovascular diseases. Statistics show that heart failure affects more than 60 million people worldwide, indicating unmet clinical needs.

Insight database shows that currently, empagliflozin has submitted four marketing application acceptance numbers in China. The indication for type 2 diabetes was approved for marketing in 2017, while two heart failure indications are under review. The first one (JXHS2000168) targets heart failure with reduced ejection fraction, and the latter one (the acceptance number proposed for priority review today) aims to reduce the risk of cardiovascular death or hospitalization for heart failure in adult patients, regardless of left ventricular ejection fraction.

Source: Insight Database (http://db.dxy.cn/v5/home/)

Among them, the registration application for the indication of Jardiance® in adult patients with heart failure with preserved ejection fraction is based on the EMPEROR-Preserved Phase III clinical trial. The results showed that empagliflozin demonstrated a 21% relative risk reduction in the composite primary endpoint of cardiovascular death or hospitalization for heart failure in HFpEF adult patients, a result that was remarkable.

At the same time, analysis of key secondary endpoints of the trial showed that empagliflozin also reduced the relative risk of first and repeat hospitalizations for heart failure by 27% and significantly slowed kidney function decline. The full results of this clinical trial were presented in August 2021 at the European Society of Cardiology (ESC) Congress and simultaneously published in The New England Journal of Medicine.