The European Commission granted approval for extension of the label of finerenone in the EU to patients with early stages of CKD and T2DM. Early stages is defined as stages 1-2 of CKD according to an eGFR of ≥60 ml/min/1.73m2, following KDIGO classification. The approval is based on results from the phase III FIGARO-DKD study that showed that treatment with finerenone results in reduced risk of CV events in a broad population of patients with stages 1-4 CKD and T2DM. Finerenone is now indicated for the treatment of CKD (with albuminuria) associated with T2DM in adults.

In the FIGARO-DKD trial , the efficacy and safety of finerenone compared to placebo in addition to standard of care was investigated in ~7400 patients with CKD and T2DM.

Source: press release Bayer, February 10, 2023