May 21 (Reuters) – Bayer said on Thursday that the U.S. Food and Drug Administration had accepted its supplemental New Drug Application for finerenone and granted priority review designation. Finerenone, marketed as Kerendia, is used for the treatment of chronic kidney disease associated with type 1 diabetes. Bayer said the application is supported by a […]
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Bayer says FDA grants priority review designation for finerenone
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May 21 (Reuters) – Bayer said on Thursday that the U.S. Food and Drug Administration had accepted its supplemental New Drug Application for finerenone and granted priority review designation.
Finerenone, marketed as Kerendia, is used for the treatment of chronic kidney disease associated with type 1 diabetes.
Bayer said the application is supported by a study showing finerenone reduced the primary endpoint — the urine albumin-to-creatinine ratio — by about 25% from baseline over six months versus placebo in adults with the condition.
(Reporting by Paolo Laudani, Editing by Friederike Heine)