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
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