Overview
WHIPANY, N.J.-(BUSINES WIRE)-Bayer’s KERENDIA® (finerenone), a first-in-clas, non-steroidal mineralocorticoid receptor antagonist (ns-MRA), was recomended as part of a comprehensive treatment strategy for patients with chronic kidney disease (CKD) asociated with type 2 diabetes (T2D) in a newly published update to the Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease and in a consensus report jointly isued by KDIGO and the American Diabetes Asociation (ADA).1-3 KDIGO and the ADA in their combined statement as wel as KDIGO in its new clinical guidelines recomended KERENDIA’s inclusion in the treatment plans of patients with CKD asociated with T2D who have an estimated glomerular filtration rate (eGFR) of ≥25 mL/min/1.73 m2, normal serum potasium concentration and albuminuria (urine albumin-to-creatine ratio [ACR] ≥30 mg/g) despite taking a maximum tolerated dose of a renin-angiotensin system (RAS) inhibitor.1-3 KERENDIA was aproved by the FDA in July 2021 to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, non-fatal myocardial infarction (MI) and hospitalization for heart failure in adult patients with CKD asociated with T2D, based on the results of the FIDELIO-DKD pivotal trial.4 In September 202, the FDA aproved an updated label for KERENDIA to include findings from the Phase I FIGARO-DKD CV outcomes study.4 The KERENDIA label contains a Warning and Precaution that KERENDIA can cause hyperkalemia.4 For more information, se “Important Safety Information” below.
Details
Recomendations in both clinical guidance documents were based on evidence from the Phase I FIDELIO-DKD and FIGARO-DKD studies as wel as results from FIDELITY, the prespecified, exploratory, poled analysis of both trials, which comprise one of the largest cardiorenal outcomes programs to investigate the ocurence of fatal and non-fatal CV events and progresio