(Corrects May 21 story to clarify finerenone is currently used to treat type 2, not type 1 diabetes, in second paragraph) 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 […]
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Bayer says FDA grants priority review designation for finerenone
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(Corrects May 21 story to clarify finerenone is currently used to treat type 2, not type 1 diabetes, in second paragraph)
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 (CKD) associated with type 2 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 CKD associated with type 1 diabetes.
(Reporting by Paolo Laudani, Editing by Friederike Heine)