FDA Approves KERENDIA to Treat Chronic Kidney Disease Associated with Type 1 Diabetes in Adults

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). Approximately 20 to 30 percent of people in the U.S. with T1D also have CKD, which puts them at risk of kidney disease progression and kidney failure.

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). 

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) greater than or equal to 40 percent.

“For more than three decades, people with chronic kidney disease and type 1 diabetes have had limited options to address the risk of kidney disease progression,” said Janet McGill, MD, MA, FACE, FACP, professor of medicine in the division of endocrinology, metabolism and lipid research at Washington University School of Medicine in St. Louis, and co-chair of the study’s executive committee. “The approval of KERENDIA to reduce UACR, which is expected to slow chronic kidney disease progression in adults with type 1 diabetes, provides an important new treatment option for a population that has continued to face substantial unmet need.”