Finerenone receives positive CHMP opinion for EU-label extension for broad range of patients with chronic kidney disease and type 2 diabetes.- Bayer HealthCare
Bayer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (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 III FIGARO-DKD study.
The study demonstrated that finerenone reduced the risk of cardiovascular events in a broad population of patients with stages 1-4 CKD and T2D. The CHMP recommended the approval of the extension of the indication of Kerendia (10 mg or 20 mg) to early stages of CKD associated with T2D: "Kerendia is indicated for the treatment of chronic kidney disease (with albuminuria) associated with type 2 diabetes in adults".
The final decision by the European Commission, authorizing marketing approval in the European Union, is expected early in 2023.
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