FDA accepts Bayer sNDA for Kerendia in CKD without diabetes, backed by FIND-CKD

On 8 October 2026, Bayer said the US FDA accepted its supplemental new drug application (sNDA) for KERENDIA (finerenone) for adults with chronic kidney disease (CKD) without diabetes on standard of care. This is acceptance for review, not approval. Kerendia is already approved for CKD with type 2 diabetes, CKD with type 1 diabetes (UACR criteria), and heart failure with LVEF ≥40%.

FIND-CKD evidence

• Support comes from FIND-CKD (NCT05047263), a randomised, double-blind, placebo-controlled multicentre phase 3 trial published in the New England Journal of Medicine (Heerspink et al., doi:10.1056/NEJMoa2604625).
• 1,584 adults with CKD without diabetes on maximally tolerated ACEI/ARB; among Kerendia-arm etiologies, about 56% glomerular (including IgAN, FSGS) and 30% hypertensive/ischemic.
• Primary: eGFR slope to month 32: −3.3 vs −4.0 mL/min/1.73 m²/year (difference 0.7; 95% CI 0.3–1.1; p**<0.001**).
• Secondary composite kidney–CV (kidney failure, sustained eGFR drop ≥57%, HF hospitalisation, CV death): HR 0.77 (95% CI 0.60–0.99; p=0.04).

Safety and limitations

• TEAEs 68.3% vs 65.4%; serious AEs 20.9% vs 21.2%; hyperkalemia 17% vs 13.3%; serious hyperkalemia <1%.
• sNDA acceptance ≠ approval; primary endpoint is a surrogate eGFR slope; hyperkalemia remains a risk.
• Not medical advice — talk to your doctor.