On Sept. 17, 2026, Bayer announced that the U.S. Food and Drug Administration (FDA) approved KERENDIA® (finerenone) to reduce urinary albumin-to-creatinine ratio (UACR), which is expected to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline and end-stage kidney disease in adults with chronic kidney disease (CKD) associated with type 1 diabetes (T1D), following the agency’s Priority Review of the supplemental New Drug Application (sNDA).

The FDA approved KERENDIA to reduce UACR, which is expected to slow chronic kidney disease progression in adults with CKD associated with T1D. This approval is important for patients, as it is the first proven therapeutic advance in CKD associated with T1D in more than 30 years.

Approval was supported by data from the Phase III FINE-ONE clinical trial in adult patients with CKD associated with T1D. It was also supported by Phase III data from the FIDELIO-DKD and FIGARO-DKD trials in adults with CKD associated with type 2 diabetes (T2D). Approximately 20-30% of people in the U.S. with T1D also have CKD which puts them at risk of kidney disease progression and kidney failure.

KERENDIA is also approved to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with CKD associated with T2D.

In addition, KERENDIA is approved to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (HF LVEF) ≥40%.