Bayer: FDA approves finerenone (Kerendia) for CKD in type 1 diabetes

Regulatory decision

The U.S. Food and Drug Administration has approved Kerendia (finerenone), a selective non‑steroidal mineralocorticoid receptor antagonist, for treatment of adult patients with chronic kidney disease associated with type 1 diabetes. The indication is to reduce urine albumin‑to‑creatinine ratio (UACR), which is expected to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline and progression to end‑stage kidney disease.

Clinical evidence

The approval is based on the Phase III FINE-ONE study and supportive pooled analyses. FINE-ONE randomized 242 participants across more than 80 sites in nine countries. Finerenone reduced the primary endpoint — relative change in UACR — by 25% over six months versus placebo; reductions versus placebo were 22% at Month 3 and 28% at Month 6. At any time after baseline, 68.1% of finerenone recipients achieved a ≥30% UACR reduction versus 46.6% with placebo. The safety profile in FINE-ONE was broadly consistent with prior data in CKD associated with type 2 diabetes.

Context and precedent

The FDA granted Priority Review in May 2026. Kerendia has been approved in the U.S. since 2021 for CKD associated with type 2 diabetes and since 2025 for symptomatic chronic heart failure with LVEF ≥40%. Finerenone has been evaluated in more than 20,000 patients across CKD and heart failure populations; pooled FIDELIO‑DKD and FIGARO‑DKD analyses attributed over 80% of kidney benefit to UACR reductions.

Unmet need

Approximately 30% of people with type 1 diabetes in the U.S. develop CKD. Despite glucose and blood‑pressure management and ACE inhibitor/ARB therapy, residual risk remains high, with up to a quarter progressing to end‑stage kidney disease.