FDA accepts Bayer application for finerenone in chronic kidney disease without diabetes

Bayer has announced that the U.S. Food and Drug Administration has accepted a supplemental New Drug Application for finerenone, marketed as Kerendia, for a potential new indication in adults with chronic kidney disease without diabetes.

The application is supported by results from the Phase III FIND-CKD study.

In the trial, finerenone added to standard of care significantly delayed kidney disease progression and reduced cardiovascular and kidney-related events compared with placebo in adults with chronic kidney disease who did not have diabetes.

Finerenone is a non-steroidal mineralocorticoid receptor antagonist designed to block mineralocorticoid receptor overactivation, a biological pathway associated with kidney disease progression and cardiovascular damage.

Christian Rommel, Global Head of Research and Development at Bayer’s Pharmaceuticals Division, said people with chronic kidney disease without diabetes may experience progressive loss of kidney function before symptoms become apparent.

He said the FDA acceptance represents an important step towards potentially extending finerenone to a broader population with limited treatment options.

Bayer estimates that around 850 million people worldwide live with chronic kidney disease, including more than 35 million adults in the U.S.

The company said approximately 50% to 70% of people with chronic kidney disease may have the condition without diabetes.

Causes can include hypertension-related kidney disease and glomerular diseases such as immunoglobulin A nephropathy and focal segmental glomerulosclerosis.

Despite current standards of care, patients with chronic kidney disease without diabetes remain at increased risk of kidney failure and cardiovascular complications.

Bayer said chronic kidney disease linked to hypertension is the second most common cause of kidney failure.

Patients with advanced chronic kidney disease without diabetes also face a substantially increased risk of fatal cardiovascular events compared with the general population without chronic kidney disease.

The FIND-CKD programme is intended to evaluate whether finerenone can provide additional kidney and cardiovascular protection in this broader patient group.

If approved, the new indication would expand the use of finerenone beyond its existing chronic kidney disease settings.

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