Berlin: Bayer has recently announced that the Japanese Ministry of Health, Labour, and Welfare (MHLW) has granted marketing authorization for finerenone under the brand name Kerendia.Kerendia (10 mg or 20 mg), a non-steroidal, selective mineralocorticoid receptor (MR) antagonist, is approved for the treatment of chronic kidney disease and type 2 diabetes, excluding patients with end-stage...
Berlin: Bayer has recently announced that the Japanese Ministry of Health, Labour, and Welfare (MHLW) has granted marketing authorization for finerenone under the brand name Kerendia.
Kerendia (10 mg or 20 mg), a non-steroidal, selective mineralocorticoid receptor (MR) antagonist, is approved for the treatment of chronic kidney disease and type 2 diabetes, excluding patients with end-stage renal disease or on dialysis.
The approval is based on the results of the pivotal Phase III studies, FIDELIO-DKD and FIGARO-DKD. The FIDELIO-DKD study was presented at the American Society of Nephrology's (ASN) Kidney Week 2020; the FIGARO-DKD study was presented at ESC Congress 2021. Both studies were published in the New England Journal of Medicine simultaneously with the congress presentations in October 2020 and August 2021, respectively.
In Japan, an estimated 13.3 million people have chronic kidney disease (CKD), a common and potentially deadly condition that is widely underrecognized. Type 2 diabetes and high blood pressure are the most common causes of CKD. Up to 40% of people with T2D will develop CKD. Finerenone is different to existing CKD in T2D treatments. It acts by blocking mineralocorticoid receptor (MR) overactivation, which contributes to CKD progression and cardiovascular damage.
"There is a high burden of type 2 diabetes in Japan, and a large proportion of people with type 2 diabetes develop chronic kidney disease. Despite well-controlled blood glucose levels and blood pressure, patients with chronic kidney disease and type 2 diabetes remain at risk of chronic kidney disease progression and cardiovascular death," said Dr. Michael Devoy, Chief Medical Officer and Head of Medical Affairs and Pharmacovigilance at Bayer's Pharmaceuticals Division. "We look forward to providing patients and physicians in Japan with a new treatment option to delay kidney disease progression and reduce the risk of cardiovascular events. The approval of finerenone offers a new path to protect patients from further kidney and cardiovascular damage through addressing MR overactivation, a key driver of CKD progression, which is unaddressed by currently available therapies."
Based on the positive results of the FIDELIO-DKD Phase III study, Kerendia was granted marketing authorization in the European Union in February 2022 and was approved by the U.S. Food and Drug Administration (USFDA) in July 2021. Finerenone has also been submitted for marketing authorization in multiple other countries worldwide and these applications are currently under review.
Read also: Bayer applies in EU for extension of Indication to Finerenone
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