FDA accepts Bayer supplemental application for Finerenone in non-diabetes CKD

The supplemental New Drug Application (sNDA) was based on the positive Phase III FIND-CKD study results

Bayer announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for finerenone (Kerendia). The application seeks a new indication to treat adults with chronic kidney disease (CKD) without diabetes. This submission is supported by data from the pivotal Phase III FIND-CKD clinical trial. The study demonstrated that adding finerenone to the current standard of care significantly slows the progression of kidney disease and lowers the risk of combined cardiovascular and kidney events compared to a placebo in this specific patient population.

“For many people living with CKD without diabetes, kidney function can decline silently for years before symptoms become apparent, while the risk of kidney failure and cardiovascular complications continues to rise,” said Dr. Christian Rommel, Global Head of Research and Development at Bayer’s Pharmaceuticals Division.

“The FDA’s acceptance of our application marks an important step toward potentially expanding the use of finerenone, a non-steroidal mineralocorticoid receptor antagonist (nsMRA), to a broader group of patients who still have few treatment options and may benefit from the cardio-kidney protective effects of finerenone. By targeting mineralocorticoid receptor overactivation, finerenone addresses a pathway implicated in kidney disease progression and cardiovascular damage.”

Chronic kidney disease (CKD) affects an estimated 850 million people globally, including more than 35 million adults in the United States. Notably, 50% to 70% of these patients live with CKD without having diabetes. For individuals whose condition advances to kidney failure, more than 3.5 million rely on dialysis treatments, a therapy that carries a 5-year survival rate of roughly 40% once initiated.

Chronic kidney disease (CKD) without diabetes stems from various causes, most commonly high blood pressure and glomerulonephritis—such as immunoglobulin A nephropathy (IgAN) or focal segmental glomerulosclerosis (FSGS). Even with standard treatment, these patients still face a high risk of kidney failure and heart problems.

CKD linked to hypertension is the second most common cause of kidney failure. Patients with advanced CKD without diabetes also face a markedly higher risk of fatal cardiovascular events, about 2.6 times that of the general population without CKD, which increases further as kidney function declines.