For the first time in more than three decades, the FDA has approved a treatment for chronic kidney disease (CKD) associated with type 1 diabetes (T1D) in adults.
Bayer's Kerendia (finerenone) will provide a new option for the approximately 30% of people with T1D who are at risk of developing CDK, which puts them at a higher risk for kidney failure. The approval is based partially on positive results from the phase 3 FINE-ONE study, which showed a statistically-significant reduction of 25% in urine albumin-to-creatinine ratio from baseline over six months. The expectation is that the oral drug will reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline and end-stage kidney disease.
Kerendia is a selective, non-steroidal mineralcorticoid receptor antagonist (nsMRA). Bayer received Priority Review designation for its sNDA in May 2026 for CKD associated with T1D. The drug is already approved for adult patients with CKD with type 2 diabetes and for adults with symptomatic chronic heart failure with left ventricular ejection fraction ≥ 40%.