Bayer announced that it received approval from the US Food and Drug Administration (FDA) for a label update for Kerendia (finerenone) to include findings from the phase III FIGARO-DKD cardiovascular (CV) outcomes study in patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). The positive data from the pivotal phase III FIGARO-DKD study demonstrated that finerenone significantly reduced the risk of cardiovascular events in adult patients with CKD and T2D. Results from the trial were presented at ESC Congress 2021, and simultaneously published in the New England Journal of Medicine.
Patients living with chronic kidney disease associated with type 2 diabetes are three times more likely to die from a cardiovascular event than those with type 2 diabetes alone. FIGARO-DKD is the first contemporary phase III CV outcomes trial to show CV benefit in a patient population where the majority of patients was in earlier CKD stages (stages 1-2 CKD, defined as estimated glomerular filtration rate [eGFR] =60 ml/min/1.73m2) with albuminuria. With the addition of these study findings, the US label now includes clinical trial data from more than 13,000 patients with CKD associated with T2D based on FIDELIO-DKD and FIGARO-DKD.
