Empagliflozin New Indication Application Accepted in China for Heart Failure with Preserved Ejection Fraction

By Medicine View

On the 17th, the CDE announced that a new indication for empagliflozin tablets had been submitted and accepted in China. Empagliflozin is an SGLT2 inhibitor jointly developed by Boehringer Ingelheim and Eli Lilly and Company. It won the "International Prix Galien" Best Pharmaceutical Agent of the Year award, known as the "Nobel Prize of the pharmaceutical industry," in 2018. According to a press release issued by Eli Lilly in September this year, the indication applied for this time is presumed to be – for adult patients with heart failure with preserved ejection fraction.

Empagliflozin is a highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor taken orally once daily. In patients with type 2 diabetes with higher blood glucose levels, empagliflozin prevents the kidneys from reabsorbing sugar by inhibiting SGLT2, allowing more sugar to be excreted in the urine. Additionally, empagliflozin reduces salt reabsorption, increasing salt excretion and reducing fluid load in the body’s vascular system. The changes in sugar, salt, and water metabolism induced by empagliflozin may contribute to a reduction in cardiovascular mortality.

In the United States, empagliflozin has been approved by the FDA for the treatment of multiple indications, including type 2 diabetes, to reduce the risk of cardiovascular death in adult patients with type 2 diabetes and cardiovascular disease, as well as to reduce the risk of cardiovascular death and hospitalization in adult patients with heart failure with reduced ejection fraction. Recently, the FDA also granted priority review status to empagliflozin's supplemental New Drug Application (sNDA) for reducing the risk of cardiovascular death and hospitalization in heart failure patients, regardless of the patient’s left ventricular ejection fraction.

In China, empagliflozin was first approved in September 2017 for improving glycemic control in patients with type 2 diabetes. In November 2020, Boehringer Ingelheim and Eli Lilly and Company also submitted a new indication application in China for the use of empagliflozin in treating adult patients with heart failure with reduced ejection fraction.

On September 30 this year, Eli Lilly issued a press release stating that it had submitted a registration application to the CDE for a new indication of empagliflozin for adult patients with heart failure with preserved ejection fraction. The application is based on the results of a Phase 3 clinical trial named EMPEROR-Preserved. The full results of the trial were simultaneously published in the European Society of Cardiology (ESC) and The New England Journal of Medicine (NEJM) in August this year.

Data Show: Compared with placebo, empagliflozin reduced the relative risk of cardiovascular death or hospitalization for heart failure by 21% in adult patients with heart failure with preserved ejection fraction, reaching the primary endpoint of the trial. Analysis of key secondary endpoints also showed that empagliflozin reduced the relative risk of first and recurrent hospitalizations for heart failure by 27% and significantly slowed kidney function decline. In addition, regardless of whether diabetes was present, empagliflozin reduced the combined risk of heart failure-related death or hospitalization in patients with preserved ejection fraction heart failure.

Heart failure, caused by a variety of factors, is a common and serious chronic condition that cannot be cured. Based on ejection fraction, heart failure can generally be divided into two major categories: heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF). Among these, HFpEF patients are predominantly elderly women and most have comorbidities. Due to its high prevalence, poor prognosis, and the lack of clinically validated therapies, there is a significant unmet need for HFpEF patients. We hope that the new indication registration application for empagliflozin proceeds smoothly, bringing new treatment options to patients as soon as possible.

References:

[1] Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Nov. 17, 2021, from https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

[2] Jardiance® submitted a registration application in China for the indication in adult patients with heart failure with preserved ejection fraction. Retrieved Sep 30, 2021, from https://mp.weixin.qq.com/s/Tx5lnjYtZKPIuf4xH_ePJA

[3] Anker et al., (2021). Empagliflozin in Heart Failure with a Preserved Ejection Fraction. NEJM, DOI: 10.1056/NEJMoa2107038

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