FDA Grants Priority Review for Bayer Kidney Disease Drug

The FDA granted priority review for Bayer's finerenone to treat type 1 diabetes kidney disease. The study showed a 25 percent reduction in a key disease marker.

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BAYER AG-REG said the U.S. Food and Drug Administration accepted its supplemental New Drug Application for finerenone and granted priority review designation. The application seeks to expand the drug's use to adults with chronic kidney disease (CKD) associated with type 1 diabetes. Finerenone is already approved for CKD associated with type 2 diabetes.

Clinical Data Drives Regulatory Fast-Track

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