German pharmaceutical and life sciences company Bayer AG (ETR:BAYN) (OTC:BAYRY) announced on Thursday that the US Food and Drug Administration (FDA) has accepted and granted Priority Review to its supplemental New Drug Application for KERENDIA (finerenone) as a treatment for adults with type 1 diabetes and chronic kidney disease.

If approved for the investigational use, KERENDIA would become the first non-steroidal mineralocorticoid receptor antagonist (MRA) indicated for adults with type 1 diabetes and chronic kidney disease.

The application is supported by data from the Phase III FINE-ONE trial, which showed that KERENDIA significantly reduced urine albumin-to-creatinine ratio over six months compared with placebo when used alongside standard of care.

Bayer said the submission also included pooled Phase III data from the FIDELIO-DKD and FIGARO-DKD trials involving adults with chronic kidney disease associated with type 2 diabetes.

The company noted that approximately 20% to 30% of people in the United States with type 1 diabetes also have chronic kidney disease, increasing the risk of cardiovascular events and kidney failure.

KERENDIA has been approved since 2021 for reducing cardiovascular and kidney disease risks in adults with chronic kidney disease associated with type 2 diabetes. In July 2025, the FDA also approved KERENDIA for reducing cardiovascular death, heart failure hospitalisation and urgent heart failure visits in adults with heart failure and left ventricular ejection fraction of 40% or greater.