Bayer Finerenone gets USFDA approval to treat CKD associated with type 2 diabetes
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Berlin: Bayer has announced that the U.S. Food and Drug Administration (FDA) has approved finerenone, the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist, under the brand name Kerendia.
Finerenone 10 mg or 20 mg is indicated to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).
The approval of finerenone by the FDA is based on the positive results of the pivotal Phase III FIDELIO-DKD study, presented at the American Society of Nephrology's (ASN) Kidney Week Reimagined 2020 and simultaneously published in the New England Journal of Medicine in October 2020, and follows Priority Review designation granted by the FDA in January 2021.
"There are more than 160 million patients living with CKD and T2D worldwide. Even when blood glucose levels and blood pressure are well-controlled, patients still remain at risk of CKD progression. This means there is a high unmet medical need for early intervention to prevent further end-organ damage and premature death by slowing patients' rate of decline in kidney function as well as reducing cardiovascular risk," said Professor George L. Bakris, MD, Department of Medicine, American Heart Association Comprehensive Hypertension Center, University of Chicago Medicine, USA and principal investigator of the FIDELIO-DKD trial. "The approval of finerenone offers a new path to protect patients from further kidney damage through addressing MR overactivation, a key driver of CKD progression, which is unaddressed by currently available therapies."
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