Bayer’s finerenone sNDA accepted by FDA for CKD without diabetes

Regulatory update

The U.S. Food and Drug Administration has accepted Bayer’s supplemental New Drug Application for finerenone (Kerendia/Firialta) to support a potential new indication in adults with chronic kidney disease (CKD) without diabetes. The filing is based on results from the pivotal Phase III FIND‑CKD study.

FIND‑CKD results

FIND‑CKD enrolled more than 1,500 patients with CKD without diabetes across a broad range of etiologies, including hypertension‑linked and glomerular diseases. Over 32 months, finerenone produced a statistically significant 0.7 ml/min/1.73 m2/year slower annual decline in eGFR versus placebo and reduced the risk of the key secondary composite cardiovascular‑kidney outcome by 23%. Additional secondary endpoints, including composites of sustained ≥57% eGFR decline or kidney failure and of hospitalization for heart failure or cardiovascular death, showed results consistent with the overall profile.

Safety and mechanism

Finerenone is a selective, non‑steroidal mineralocorticoid receptor antagonist that targets MR overactivation, a pathway implicated in CKD progression and cardiovascular damage. In FIND‑CKD it was reported to be well tolerated, consistent with its established safety profile.

Clinical programme and current status

Finerenone’s Phase III programme (FINEOVATE) comprises twelve studies, including the THUNDERBALL CKD trials FIDELIO‑DKD, FIGARO‑DKD, FIND‑CKD and FINE‑ONE, plus other studies and pediatric trials. Since 2021 finerenone has been approved for CKD associated with type 2 diabetes in more than 100 countries and for heart failure with LVEF ≥40% in multiple jurisdictions; it is currently not approved for CKD without diabetes.