2022 | HFSA

Bayer’s KERENDIA® (finerenone) Receives Updated Label to Include Findings From Phase III FIGARO-DKD Cardiovascular Outcomes Study in Patients With Chronic Kidney Disease and Type 2 Diabetes

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WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer announced today that it received approval from the United States (U.S.) Food and Drug Administration (FDA) for an update to the label for KERENDIA® (finerenone), a first-in-class nonsteroidal mineralocorticoid receptor antagonist (MRA), to include findings from the FIGARO-DKD cardiovascular (CV) outcomes study in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D).1 FIGARO-DKD is the first contemporary Phase III CV outcomes trial with the majority of patients with earlier stage (1-2) CKD (defined as estimated glomerular filtration rate [eGFR] ≥60 mL/min/1.73 m2) with albuminuria to show CV benefit in patients with CKD associated with T2D.1

KERENDIA provides dual cardiorenal risk reduction in adults with CKD associated with T2D.1 KERENDIA was approved in the U.S. by the FDA in July 2021 to reduce the risk of sustained eGFR decline, end-stage kidney disease, CV death, non-fatal myocardial infarction (MI) and hospitalization for heart failure in adult patients with CKD associated with T2D, based on the results of the FIDELIO-DKD pivotal trial.1 The KERENDIA label contains a Warning and Precaution that KERENDIA can cause hyperkalemia.1 For more information, see “Important Safety Information” below.