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2021 | HFSA

Bayer’s KERENDIA® (finerenone) Receives U.S. FDA Approval for Treatment of Patients with Chronic Kidney Disease Associated with Type 2 Diabetes

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WHIPPANY, N.J.--(BUSINESS WIRE)-- Bayer announced today the United States (U.S.) Food and Drug Administration (FDA) has approved KERENDIA® (finerenone), a first-in-class nonsteroidal mineralocorticoid receptor antagonist (MRA) indicated to reduce the risk of sustained eGFR decline, kidney failure, cardiovascular death, non-fatal myocardial infarction (MI) and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).1 The approval is based on the results of the pivotal Phase III FIDELIO-DKD trial data that demonstrated positive kidney and cardiovascular outcomes in patients with CKD associated with T2D, published in the New England Journal of Medicine in October 2020, and follows priority review designation granted by the FDA.1,6

“The patient population included in the trial that supported the approval of KERENDIA were at risk of chronic kidney disease progression despite receiving standard of care treatment to control blood pressure and blood glucose,”1,6 said George Bakris, M.D., University of Chicago and lead FIDELIO-DKD study investigator. “In people with chronic kidney disease associated with type 2 diabetes, physicians now have a new treatment to provide kidney protection.”1,3,6