Bayer today announced the launch of Finerenone under the brand name KerendiaTM 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 India1. Over 40% of all patients with diabetes will develop chronic kidney disease2. Seventy-four million people suffer from diabetes in India and this figure is likely to increase to ninety-three million by 2030, making it an epidemic3. The number of people with diabetes in India is the second highest in the world, after China.
Mr. Manoj Saxena, Managing Director, 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 failure4. 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 disease5. 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% Glomerular Filtration Rate(eGFR) kidney composite outcome by 23% on top of optimised Renin-angiotensin system (RAS) blockade, and significantly reduced the risk of the composite CV outcome by 14%
Based on the results of the clinical trials studies, Finerenone was approved by the U.S. 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.)