Bayer's Kerendia receives USFDA approval for kidney and heart disease in Type 2 diabetes patients

July 16, 20210

The USFDA has approved Finerenone (Kerendia) which is now the first and only nonsteroidal mineralocorticoid receptor antagonist (MRA) for treating patients with chronic kidney disease (CKD) associated with type 2 diabetes. Kerendia was explicitly approved to reduce the risk of kidney failure, heart attack, heart failure hospitalization, and cardiovascular death in adult patients with diabetes related chronic kidney disease. 

Kerendia acts by blocking the overactivation of the mineralocorticoid receptor, which contributes to fibrosis and inflammation. Kerendia received accelerated approval through both Fast Track and Priority Review designations.

The approval of KERENDIA is supported by FIDELIO-DKD trial, where finerenone beat placebo by slowing down kidney failure (when patients need dialysis or a transplant to survive) or decreasing estimated glomerular filtration rate (eGFR) by almost 40%. In another study FIGARO-DKD, Finerenone significantly reduced the composite risk of time to first occurrence of cardiovascular death or nonfatal myocardial infarction, stroke or hospitalization for heart failure. The FIGARO-DKD study was part of the largest Phase III clinical trial program to date in CKD. The study included approximately 7,400 patients from more than 1,000 sites across 47 countries worldwide.  

A side effect found in Kerendia is it can cause hyperkalemia. The risk for developing hyperkalemia increases with decreasing kidney function and is greater in patients with higher baseline potassium levels or other risk factors for hyperkalemia.  

Kerendia is expected to be available in the U.S. beginning the end of July 2021. Finerenone has also been submitted for marketing authorization in the European Union. Kerendia’s major competitors in market are AstraZeneca’s Farxiga (dapagliflozin) and Johnson & Johnson’s INVOKANA™ (canagliflozin) , both of which are sodium glucose co-transporter 2 (SGLT2) inhibitors. Eli Lilly and Boehringer Ingelheim could be just months away from a CKD indication for their class-leading SGLT2 drug Jardiance (empagliflozin) which is currently under a fast-track review by the FDA. 

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