Posted by Michael Wonder on 18 Dec 2022
Finerenone receives positive CHMP opinion for EU label extension for broad range of patients with chronic kidney disease and type 2 diabetes
16 December 2022 - CHMP opinion is based on the results from the Phase 3 FIGARO-DKD cardiovascular outcomes trial in patients with chronic kidney disease and type 2 diabetes mellitus, which included approximately 7,400 patients across a broad range of disease severity, including stages 1-4 chronic kidney disease associated with type 2 diabetes mellitus.
Bayer announced today that the CHMP of the EMA has adopted a positive opinion, recommending a label extension for Kerendia (finerenone, 10 mg or 20 mg) to include results on cardiovascular outcomes from the Phase 3 FIGARO-DKD trial.
