Bayer Korea Receives Domestic Approval for Chronic Kidney Disease Treatment 'Kerendia'

Logo of 'Kerendia,' Bayer Korea's treatment for type 2 diabetes with accompanying kidney disease

[Asia Economy Reporter Chunhee Lee] Bayer Korea announced on the 11th that its treatment for type 2 diabetes-associated kidney disease, Kerendia (active ingredient 'finerenone'), received domestic approval from the Ministry of Food and Drug Safety on the 10th.

Kerendia was approved to reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR), progression to end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization due to heart failure in adult patients with chronic kidney disease (CKD) and type 2 diabetes.

CKD related to type 2 diabetes is considered the most common cause of kidney failure, with approximately 40% of diabetic patients progressing to CKD. The factors causing kidney disease in type 2 diabetes include hemodynamic changes, metabolic abnormalities, inflammation, and fibrosis. However, current treatments mainly target hemodynamic and metabolic factors, and there are no therapies targeting inflammation and fibrosis, highlighting the need for new treatment options.

Kerendia is the first non-steroidal selective mineralocorticoid receptor antagonist with a novel mechanism targeting inflammation and fibrosis in adult CKD patients with type 2 diabetes. Overactivation of mineralocorticoid receptors can cause inflammation and fibrosis, which may lead to permanent kidney damage. Kerendia inhibits mineralocorticoid receptor overactivation, thereby reducing inflammation and fibrosis and preventing kidney damage.

This approval was based on phase 3 clinical trial results comparing Kerendia with placebo in adult CKD patients with type 2 diabetes. The study involved approximately 5,700 patients across 48 countries worldwide, confirming that Kerendia suppresses CKD progression and reduces cardiovascular risk in this patient population. Participants received either Kerendia 10 mg or 20 mg in addition to standard therapy or placebo.

Clinical results showed that Kerendia significantly reduced the primary composite endpoint?end-stage kidney disease, sustained decline of 40% or more in eGFR, or kidney-related death?by about 18% compared to placebo. Key secondary endpoints, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure, were reduced by approximately 14%. The incidence of serious adverse events or adverse events related to acute kidney injury was generally similar between the two groups.

Myungkyu Noh, Head of Cardiovascular Disease Division at Bayer Korea, said, “We are pleased that Kerendia offers a new therapeutic approach directly targeting kidney inflammation and fibrosis, providing new treatment options for healthcare professionals and patients. We hope that Kerendia will ultimately slow disease progression and improve patients’ quality of life.”

This content was produced with the assistance of AI translation services.