Kerendia is granted expanded indication in the EU for broad range of patients with chronic kidney disease and type 2 diabetes.- Bayer .

The study demonstrated that Kerendia reduced the risk of CV events in a broad population of patients with stages 1-4 CKD and T2D. The indication of Kerendia (10 mg or 20 mg), a non-steroidal, selective mineralocorticoid receptor antagonist, has been extended to include early stages of CKD associated with T2D. Kerendia is now indicated for the treatment of chronic kidney disease (with albuminuria) associated with type 2 diabetes in adults.

Results from the pivotal Phase III FIGARO-DKD study were presented at the European Society of Cardiology (ESC) Congress 2021 and simultaneously published in the New England Journal of Medicine. FIGARO-DKD investigated the efficacy and safety of finerenone versus placebo in addition to standard of care on the reduction of CV morbidity and mortality in approximately 7,400 patients with CKD and T2D. The positive data from FIGARO-DKD demonstrated that finerenone significantly reduced the risk of cardiovascular events in adult patients with CKD and T2D versus placebo.

Based on the positive results of the FIDELIO-DKD Phase III study, Kerendia was granted initial marketing authorization by the European Commission in February 2022 for the treatment of CKD (stage 3 and 4 with albuminuria) associated with T2D in adults. Following this approval by the European Commission, the extended EU label for Kerendia now reflects data from more than 13,000 patients with CKD and T2D, based on both the Phase III FIDELIO-DKD and FIGARO-DKD studies.