
Pharmaceutical Product R&D Developer
Intelligent Finance APP learned on May 17 that Bayer (BAYRY.US) announced the China National Medical Products Administration (NMPA) approved the extended indication of finerenone (trade name: Kerendia) to include the cardiovascular benefits demonstrated in the Phase 3 FIGARO-DKD study. The study shows,Finerenone Reduces Cardiovascular Event Risk in Patients with Stage 1-4 Chronic Kidney Disease (CKD) Associated with Type 2 Diabetes (T2D).This approval also expands the indication of finerenone in China to the early stages of chronic kidney disease associated with type 2 diabetes.
It is reported that finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist, which has been shown in preclinical studies to block the harmful effects caused by overactivation of mineralocorticoid receptors. In patients with diabetes, overactivation of mineralocorticoid receptors is believed to lead to the progression of chronic kidney disease and cardiovascular damage through inflammation and fibrosis in target organs.
Professor Zhu Dalong from the Endocrinology Department of Nanjing Medical University's Gulou Hospital stated: "Early intervention in chronic kidney disease is crucial to slowing disease progression. Chronic kidney disease is one of the most common complications of diabetes and an independent risk factor for cardiovascular disease. Patients with type 2 diabetes should have their urine regularly tested for albumin by a doctor, and once diagnosed, comprehensive treatment should be initiated to reduce the risk of cardiovascular complications and mortality."The Phase 3 FIGARO-DKD study included patients with a wide range of disease severity, including CKD stages 1-4 associated with T2D.The expanded indications for Kerendia provide clinicians and patients with an effective option for early treatment."
Bayer AG's Chief Medical Officer, Dr. Michael Devoy, stated: "The burden of diabetes in China is significant. In 2021, 141 million adults in China were living with diabetes, facing the risk of severe complications such as CKD. Up to 40% of type 2 diabetes patients may develop CKD, so doctors should regularly monitor them for early signs of kidney disease."This expansion of indications in China supports Kerendia as a cornerstone treatment, providing doctors with a unique pathway to protect patients with chronic kidney disease associated with type 2 diabetes from further renal damage and cardiovascular events.