Bayer's New Drug Application for Finerenone Tablets Accepted by China's CDE

On February 3, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) announced in its latest public notice that it had accepted Bayer’s marketing application for finerenone film-coated tablets, an innovative therapy submitted in China. Publicly available information indicates that finerenone is a potential first-in-class non-steroidal selective mineralocorticoid receptor antagonist (MRA). Last month, the U.S. Food and Drug Administration (FDA) accepted the new drug application for this product for the treatment of chronic kidney disease in patients with type 2 diabetes and granted the application priority review status.

Source: CDE Official Website

Chronic kidney disease is one of the most common complications of diabetes and an independent risk factor for cardiovascular disease. Approximately 40% of patients with type 2 diabetes develop chronic kidney disease. In patients with type 2 diabetes, chronic kidney disease is a leading cause of end-stage renal disease and kidney failure, with advanced cases potentially requiring dialysis or kidney transplantation for survival. It is well established that excessive activation of mineralocorticoid receptors can trigger detrimental processes in the kidneys and heart, such as inflammation and fibrosis.

Finerenone (BAY94-8862) is an investigational nonsteroidal selective mineralocorticoid receptor antagonist that mitigates the harmful effects of excessive mineralocorticoid receptor (MR) activation. Previously, the FDA granted finerenone Fast Track designation.

According to the Drug Clinical Trial Registration and Information Publicity Platform, Bayer has registered and conducted four clinical trials in China. Among these, one Phase III international multicenter clinical trial evaluating the efficacy and safety of finerenone in the treatment of diabetic kidney disease has been completed. Based on this, it is speculated that the indication for which finerenone is seeking marketing approval in China may be diabetic kidney disease.

Previously, finerenone achieved positive results in the Phase 3 clinical trial named FIDELIO-DKD. This was a randomized, double-blind, placebo-controlled Phase 3 trial led by Dr. George Bakris, Professor of Medicine at the University of Chicago, conducted across more than 1,000 clinical centers in 48 countries and regions worldwide, enrolling a total of 5,734 patients with type 2 diabetes (T2D) and chronic kidney disease (CKD). According to an earlier press release from Bayer, the FIDELIO-DKD study is the first large-scale trial in patients with CKD and T2D to employ a primary composite endpoint focused on renal outcomes and to yield positive results.

The results demonstrated that finerenone provides significant renal and cardiovascular benefits in patients with type 2 diabetes and chronic kidney disease. When added to the maximally tolerated doses of guideline-recommended therapy, finerenone reduced the risk of kidney disease progression by 18% and lowered the composite risk of cardiovascular events by 14% over a median follow-up period of 2.6 years, compared with current standard of care. These findings were published simultaneously in the New England Journal of Medicine (NEJM).

Dr. Bakris stated that the positive results of this study are highly significant, as patients with diabetic kidney disease have historically had few treatment options. The new therapy enables patients to delay the initiation of dialysis, thereby potentially postponing the need for kidney transplantation. The reduction in cardiovascular events represents an additional benefit associated with slowing the progression of kidney disease.

Congratulations on the acceptance of Bayer’s marketing application for finerenone in China. We hope for its early approval to benefit more patients with diabetic kidney disease.

Note: This article aims to introduce advances in medical and health research and does not constitute a recommendation for treatment plans. For guidance on treatment options, please consult a qualified healthcare provider at an accredited medical institution.

References

[1] Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Feb 3, 2021, from http://www.cde.org.cn/news.do?method=changePage&pageName=service&frameStr=21#

[2] Finerenone Significantly Reduces Renal and Cardiovascular Events in Adult Patients with Chronic Kidney Disease and Type 2 Diabetes. Retrieved Oct 26, 2020, from https://mp.weixin.qq.com/s/92Mhfmt2ldX5zapiBtuuvA

[3] Bayer’s Finerenone Meets Primary Endpoint in Phase III FIDELIO-DKD Renal Outcomes Study in Patients With Chronic Kidney Disease and Type 2 Diabetes. Retrieved July 9, 2020, from https://www.businesswire.com/news/home/20200709005224/en

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