Bayer Announces Finerenone Meets Primary Endpoint in Phase III FIGARO-DKD Study, Submits Regulatory Filings for Novel MRA in Diabetic Kidney Disease

Today, Bayer announced that its investigational therapy, finerenone, met the primary endpoint in the Phase 3 FIGARO-DKD clinical trial evaluating patients with type 2 diabetes (T2D) and chronic kidney disease (CKD). Finerenone is a potential first-in-class non-steroidal selective mineralocorticoid receptor antagonist (MRA). The study demonstrated that finerenone significantly reduced the composite risk of first occurrence of cardiovascular death or non-fatal events (myocardial infarction, stroke, or hospitalization for heart failure). Finerenone has been granted Priority Review by the U.S. FDA. Additionally, its marketing application in China has been accepted.

Chronic kidney disease (CKD) is a life-threatening condition, one of the most common complications of diabetes, and an independent risk factor for cardiovascular disease. Approximately 40% of patients with type 2 diabetes (T2D) develop CKD. In patients with T2D, CKD is a leading cause of end-stage renal disease and kidney failure, with advanced-stage patients potentially requiring dialysis or kidney transplantation for survival. It is well established that excessive activation of mineralocorticoid receptors can trigger harmful processes, such as inflammation and fibrosis, in the kidneys and heart of patients with CKD and T2D.

Finerenone (BAY 94-8862) is an investigational nonsteroidal selective mineralocorticoid receptor antagonist that reduces many of the harmful effects associated with excessive activation of the mineralocorticoid receptor. In 2015, the U.S. FDA granted finerenone Fast Track designation.

FIGARO-DKD is a randomized, double-blind, placebo-controlled Phase 3 clinical study conducted in approximately 7,400 patients with type 2 diabetes and chronic kidney disease. Detailed clinical data from FIGARO-DKD will be presented at an upcoming scientific conference.

This marks the second positive Phase 3 clinical trial result for finerenone, following the favorable outcomes previously reported in the FIDELIO-DKD Phase 3 trial. Compared with current standard of care, finerenone reduced the risk of kidney disease progression by 18% and the composite risk of cardiovascular events by 14% over a median follow-up period of 2.6 years.

Note: The original text has been abridged.

References:

[1] Bayer’s Finerenone Meets Primary Endpoint in Phase III FIGARO-DKD Cardiovascular Outcomes Study in Patients With Chronic Kidney Disease and Type 2 Diabetes. May 10, 2021, from

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