CHMP recommends a label extension for Kerendia to include results of Phase III FIGARO-DKD study
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-stages 3 and 4 deleted) 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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