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Bayer: submits EU and US applications for Finerenone

(CercleFinance.com) - Late on Monday Bayer announced that it has submitted regulatory applications to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for approval of finerenone for patients with chronic kidney disease (CKD) and type 2 diabetes.


Finerenone has demonstrated renal and cardiovascular benefits in patients with CKD and type-2 diabetes in the FIDELIO-DKD phase III study.

If approved, finerenone could be a new treatment option that could slow the disease's progression, said Professor George L. Bakris, University of Chicago Medical School and lead investigator of the study.


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