Bayer's Finerenone Granted EU Approval for Early-Stage Diabetic Kidney Disease in Type 2 Diabetes

On February 10, Bayer announced that the EU had approved a new indication for finerenone in the early stages of chronic kidney disease associated with type 2 diabetes. This approval was based on the Phase III FIDELIO-DKD and FIGARO-DKD studies conducted in more than 13,000 patients with chronic kidney disease associated with type 2 diabetes.

Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist that has been shown in preclinical studies to block the harmful effects caused by overactivation of the mineralocorticoid receptor. In patients with diabetes, overactivation of the mineralocorticoid receptor is thought to lead to chronic kidney disease progression and cardiovascular damage through inflammation and fibrosis in target organs.

Based on the positive results of the Phase III FIDELIO-DKD study, finerenone was approved by the European Commission in February 2022 for adult patients with chronic kidney disease associated with type 2 diabetes (stages 3 and 4, with albuminuria).

The FIGARO-DKD study enrolled approximately 7,400 patients with chronic kidney disease associated with type 2 diabetes, spanning various stages of disease severity (stages 1-4). The study demonstrated that, compared to placebo, finerenone significantly reduced the risk of cardiovascular events in patients with chronic kidney disease associated with type 2 diabetes.

Professor Peter Rossing, Head of Complications Research at the Steno Diabetes Center Copenhagen, stated: "Patients with chronic kidney disease face an increased risk of cardiovascular events. Since chronic kidney disease progresses silently and often shows no symptoms in its early stages, patients with type 2 diabetes should be regularly monitored by their doctors for early signs of kidney disease. Once diagnosed, comprehensive treatment should be initiated to reduce the risk of cardiovascular complications and mortality."

Dr. Michael Devoy, Chief Medical Officer of Bayer's Pharmaceuticals Division, stated: "Even with good control of blood sugar and blood pressure, patients with chronic kidney disease associated with type 2 diabetes still face a high risk of kidney disease progression and cardiovascular events. Finerenone addresses a key factor related to disease progression that other therapies cannot target, providing doctors with a unique approach to protect patients from further kidney damage and the occurrence of cardiovascular events. Given that pivotal Phase III clinical studies have demonstrated finerenone’s benefits for both renal and cardiovascular outcomes in patients across various levels of disease severity, this expanded indication supports its use in the early stages of chronic kidney disease associated with type 2 diabetes."

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