MHLW (Japan) approves Kerendia to treat chronic kidney disease and type 2 diabetes, excluding patients with end-stage renal disease or on dialysis. Bayer HealthCare
Bayer 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 (previously cited) simultaneously with the congress presentations in October 2020 and August 2021, respectively.
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