Bayer launches Kerendia (finerenone), for CKD patients with diabetes
Finerenone is the first non-steroidal, selective mineralocorticoid receptor antagonist to demonstrate a significant reduction in the risk of kidney and cardiovascular events in patients with chronic kidney disease associated with type 2 diabetes
Bayer announced the launch of Finerenone under the brand name Kerendia in India. Finerenone is a first-in-class non-steroidal, selective mineralocorticoid receptor antagonist indicated for
patients with chronic kidney disease associated with type 2 diabetes. The recent Indian Chronic Kidney Disease (ICKD) study identifies diabetes as the leading cause of chronic kidney disease and end-stage kidney disease in India.
Manoj Saxena, MD, Bayer Zydus Pharma, says, “The major focus of therapy in patients with chronic kidney disease and diabetes is to prevent end-stage renal disease or kidney failure. Despite therapy, these patients often progress to kidney failure. Finerenone, therefore, offers a new treatment approach for these vulnerable patients to slow down the progression of chronic kidney disease and reduce the risk of kidney failure. It can also reduce the risk of heart disease associated with chronic kidney disease. Additionally, the economic burden of dialysis or renal transplant required for kidney failure patients can be a huge burden for patients and their families in India.”
Finerenone is different to existing CKD in T2D treatments. It acts by blocking mineralocorticoid receptor (MR) overactivation, which is thought to contribute to CKD progression and cardiovascular damage.
The pivotal Phase III clinical trial program of Finerenone involving more than 13000 patients globally was undertaken to investigate the safety and efficacy of kidney and cardiovascular outcomes in patients with chronic kidney disease associated with type 2 diabetes. The results show that Finerenone significantly reduced the risk of ≥57 per cent Glomerular Filtration Rate(eGFR) kidney composite outcome by 23 per cent on top of optimised Renin-angiotensin system (RAS) blockade, and significantly reduced the risk of the composite CV outcome by 14 per cent.
Based on the results of the clinical trial studies, Finerenone was approved by the US Food and Drug Administration (FDA) in July 2021, further granted marketing authorization by the European Commission in February 2022, and subsequently approved in India by the health authority in April 2022. As per the approval in India, Finerenone is indicated to reduce the risk of sustained Estimated eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D.)