Bayer's Finerenone Receives CDE Acceptance for New Indication in Heart Failure with LVEF ≥40%

Jan 24, 2025 10:53 CST Updated 10:53

Bayer

Pharmaceutical Product R&D Developer

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Today (January 24), the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) stated,Bayer's new indication application for finerenone tablets has been accepted. According to a press release issued by Bayer earlier this month, it has simultaneously submitted the marketing application for finerenone for heart failure indication in China and the United States.For adult heart failure patients with left ventricular ejection fraction (LVEF) ≥40%, namely heart failure patients with mildly reduced left ventricular ejection fraction (HFmrEF) or preserved left ventricular ejection fraction (HFpEF).。

Screenshot source:CDE Official Website

Finerenone is aNon-steroidal selective mineralocorticoid receptor (MR) antagonist, the product has been launched globally, includingChina、Europe, Japan, the United States, and more than 90 other countries and regions have been approved for useChronic Kidney Disease Associated with Type 2 Diabetes，Can be reducedEstimated Glomerular Filtration Rate (eGFR) continuous decline, risk of end-stage renal disease.

Heart failure is the cardiovascular disease with the fastest-growing number of cases, about half of which are heart failures with LVEF≥40%. This type of heart failure is associated with various diseases, and its complex condition makes it difficult to manage. Time trend analysis also indicates that patients with heart failure with LVEF≥40% will soon account for the majority of hospitalized heart failure patients.By targeting MR and the overactivation of the renin-angiotensin-aldosterone system (RAAS), finerenone acts on the pathogenesis of heart failure with LVEF≥40%, such as progressive fibrosis issues.。

According to the previous press release by Bayer, the submission of the marketing application for finerenone's heart failure indication to the CDE and the U.S. FDA is based on the positive results of the FINEARTS-HF study.This is a Phase 3 clinical study targeting heart failure patients with LVEF≥40% (i.e., mildly reduced or preserved LVEF), involving over 15,000 patients.. The data has been published in the New England Journal of Medicine. The results indicate that, compared with placebo, finerenone has a statistically significant improvement in cardiovascular outcomes for heart failure patients with LVEF≥40%.

Specifically, the test results showed,In heart failure patients with LVEF≥40%, finerenone reduced the composite clinical endpoint of cardiovascular death and total heart failure events by 16%, achieving the primary endpoint of the trial.. The positive data from this study meansFinerenoneThe effect is not limited to the patient group with chronic kidney disease accompanied by T2D, but also provides clinical benefits for heart failure patients (LVEF≥40%).

References:

[1] Official website of the Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Jan 24, 2025, from https://www.cde.org.cn/main/xxgk/listpage/da6efd086c099b7fc949121166f0130c

[2]Bayer Submits Finerenone Heart Failure Indication Marketing Application in China and the United States Simultaneously. Retrieved Jan 11, 2025, from https://mp.weixin.qq.com/s/_LpJNU3V7p-aZhOjElu3wQ

[3] Bayer Submits Supplemental New Drug Application to U.S. FDA Seeking New Indication for KERENDIA® (finerenone) in Patients with Heart Failure with Left Ventricular Ejection Fraction of ≥40%. Retrieved January 11, 2025, from https://www.businesswire.com/news/home/20250109213827/en

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