Expanded indication for non-steroidal MRA in EU for broad range of patients with CKD and T2DM

News - Mar. 1, 2023

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

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