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Bayer Applies for US, EU Marketing Authorization for Finerenone

By Cecilia Butini

Bayer AG said Monday that it has applied for marketing authorization with the U.S. Food and Drug Administration and the European Medicines Agency for its drug, finerenone, to be used in the treatment of chronic kidney disease and Type 2 diabetes.

The submission with the two regulatory agencies comes after receiving positive data from its Phase 3 FIDELIO-DKD study, Bayer said.

The German chemical and pharmaceutical conglomerate said the drug demonstrated benefits at the renal and cardiovascular level in patients affected by chronic kidney disease and Type 2 diabetes.

Write to Cecilia Butini at cecilia.butini@wsj.com

(END) Dow Jones Newswires

November 09, 2020 09:31 ET (14:31 GMT)

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