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.