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FDA Accepts Bayer's Filing To Expand KERENDIA Use In CKD Without Diabetes

October 08, 2026 — 03:15 am EDT

Written by RTTNews.com for RTTNews

(RTTNews) - Thursday, Bayer (BYR.L) announced that the U.S. FDA has accepted its supplemental New Drug Application (sNDA) for KERENDIA (finerenone) to treat adults with non-diabetic chronic kidney disease (CKD).

The filing is supported by results from the Phase 3 FIND-CKD trial in which KERENDIA significantly improved eGFR slope compared to placebo, indicating slowing of kidney disease progression.

KERENDIA also significantly reduced the risk of a composite kidney-cardiovascular endpoint that included kidney failure, substantial kidney function decline, hospitalization for heart failure, or cardiovascular death.

According to Bayer, the safety profile was consistent with previous Phase 3 studies, with similar rates of serious adverse events between KERENDIA and placebo.

BYR.L closed Wednesday's trading at $12.26, down 1.29%.

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