Application is submitted in the EU to extend the indication of finerenone to include early stages of CKD associated with type 2 diabetes- Bayer.

The submission is based on positive data from the FIGARO-DKD study, which demonstrated that finerenone significantly reduced the risk of cardiovascular events in adult patients with CKD and T2D. FIGARO-DKD included patients across a broad range of disease severity, including stages 1-4 CKD associated with T2D.

Results from the trial were presented at ESC Congress 2021, and simultaneously published in the New England Journal of Medicine.( previously cited). FIDELIO-DKD and FIGARO-DKD are part of the largest Phase III clinical trial program to date in CKD and T2D which demonstrated positive kidney and cardiovascular (CV) outcomes in patients with chronic kidney disease associated with type 2 diabetes.

Based on the positive results of the FIDELIO-DKD Phase III study, in February 2022, finerenone was approved in the EU for adult patients with chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes. In July 2021, finerenone was approved by the FDA to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). Finerenone has also been submitted for marketing authorization in multiple other countries worldwide and these applications are currently under review..