Bayer has submitted a marketing authorisation application in Japan seeking to expand the use of finerenone for adults with Chronic Kidney Disease (CKD) who do not have diabetes. The submission is supported by positive results from the Phase 3 FIND-CKD study, which evaluated finerenone in a broad population of patients with non-diabetic CKD.

CKD affects approximately 850 million people worldwide, with more than half of those cases occurring in people without diabetes. Despite existing standards of care, patients with non-diabetic CKD remain at risk of progressive kidney disease, kidney failure and cardiovascular complications. Common causes include hypertension-related kidney disease and glomerular diseases such as immunoglobulin A nephropathy and focal segmental glomerulosclerosis.

In Japan, nearly 20 million adults are estimated to be living with CKD, highlighting the need for additional treatment options for patients at risk of disease progression and cardiovascular events.

 Dr. Christian Rommel, Global Head of Research and Development, Bayer’s Pharmaceuticals Division, said, “This submission in Japan marks an important step toward potentially bringing finerenone to adult patients living with non-diabetic chronic kidney disease and addressing this high unmet medical need. The filing builds on the growing evidence supporting finerenone across a broad range of cardio-kidney diseases.

FIND-CKD is the largest Phase 3 study to date specifically focused on non-diabetic CKD. The trial enrolled more than 1,500 patients with different causes of non-diabetic CKD, including hypertension-related kidney disease and glomerular diseases. Participants received finerenone at doses of 10 mg or 20 mg, or placebo, in addition to standard care involving maximum tolerated labelled doses of renin-angiotensin system-blocking therapies.

Over a treatment period of more than 32 months, finerenone significantly slowed the annual decline in estimated Glomerular Filtration Rate (eGFR), a key measure of kidney function, compared with placebo. The treatment also reduced the risk of the key composite cardiovascular-kidney outcome by 23 percent.

Other secondary outcomes, including sustained eGFR decline or kidney failure and hospitalisation for heart failure or cardiovascular death, were consistent with the overall positive efficacy profile observed in the study. Finerenone was generally well tolerated, with findings consistent with its established safety profile.

Finerenone is a selective, non-steroidal mineralocorticoid receptor antagonist designed to block the harmful effects associated with excessive mineralocorticoid receptor activation. Such overactivation can contribute to kidney disease progression and cardiovascular damage through metabolic, haemodynamic, inflammatory and fibrotic mechanisms.

Marketed as Kerendia and, in selected markets, Firialta, finerenone has been approved since 2021 for adults with CKD associated with type 2 diabetes in more than 100 countries, including Japan, the US, Europe and China. It is also approved for heart failure with a left ventricular ejection fraction of 40 percent or lower in several markets. However, finerenone is not currently approved for the treatment of non-diabetic CKD.

The latest application could broaden the medicine’s role in cardio-kidney care in Japan if approved, potentially providing physicians with another treatment option for a large population of patients facing progressive non-diabetic CKD and associated cardiovascular risks.