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Bayer says FDA grants priority review designation for finerenone

By Thomson Reuters May 21, 2026 | 1:56 AM

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)