1 September 2022 - US label now inclusive of data from comprehensive Phase 3 clinical trial program (FIGARO-DKD and FIDELIO-DKD) investigating kidney and cardiovascular outcomes in more than 13,000 patients with chronic kidney disease associated with type 2 diabetes mellitus.
Bayer announced today that it received approval from the US FDA for an update to the label for Kerendia (finerenone) to include findings from the FIGARO-DKD cardiovascular outcomes study in patients with chronic kidney disease and type 2 diabetes mellitus.