German pharmaceutical and life sciences company Bayer AG (ETR:BAYN) (OTC:BAYRY) said on Thursday that the US Food and Drug Administration (FDA) has accepted its supplemental New Drug Application for KERENDIA (finerenone) for adults with chronic kidney disease (CKD) without diabetes who are receiving standard of care.

The application is supported by results from the Phase III FIND-CKD trial, in which KERENDIA significantly reduced the rate of kidney function decline compared with placebo.

KERENDIA also produced a statistically significant reduction in the risk of a secondary kidney-cardiovascular endpoint, which included kidney failure, sustained eGFR decline of at least 57%, hospitalisation for heart failure or cardiovascular death.

The safety profile was consistent with previous Phase III studies, with serious adverse events reported in 20.9% of KERENDIA patients and 21.2% of placebo patients.

FIND-CKD enrolled 1,584 adults with CKD without diabetes, with 56% of KERENDIA-treated participants having underlying glomerular disease and 30% having hypertensive or ischemic nephropathy.

More than 37 million US adults have CKD, and an estimated 50% to 70% of people with the condition do not have diabetes.

KERENDIA is already FDA-approved for several indications involving CKD associated with type 2 diabetes, CKD associated with type 1 diabetes and heart failure with left ventricular ejection fraction of at least 40%.

Bayer said the potential new indication could expand KERENDIA's use to a broader CKD population at risk of progressive kidney function loss and cardiovascular complications.