FDA approves Kerendia in chronic kidney disease (CKD) associated with type 2 diabetes – Bayer HealthCare

Bayer announced the 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).

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. The approval is supported by FIDELIO-DKD trial, which is part of the Phase III program for finerenone in CKD associated with T2D. Kerendia reduced the incidence of the primary composite endpoint of a sustained decline in eGFR of at least 40%, kidney failure, or renal death (HR 0.82, 95% CI 0.73-0.93, p=0.001). The treatment effect reflected a reduction in a sustained decline in eGFR of at least 40% and progression to kidney failure.1 There were few renal deaths during the trial.

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.