Bayer Applies for US, EU Marketing Authorization for Finerenone
09 Novembre 2020 - 03:46PM
Dow Jones News
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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