Bayer’s Kerendia wins FDA approval for CKD in adults with type 1 diabetes

• FDA cleared Bayer’s Kerendia (finerenone) for adults with chronic kidney disease tied to type 1 diabetes, its first new option in over 30 years.
• Label covers reducing urinary albumin-to-creatinine ratio, a marker expected to lower risk of sustained eGFR decline and end-stage kidney disease.
• Decision followed a Priority Review of a supplemental NDA, backed by Phase III FINE-ONE data showing a 28% UACR reduction at six months.

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