Bayer on Thursday announced the launch of Finerenone under the brand name Kerendia in India. According to the company’s press statement, Finerenone is a first-in-class non-steroidal, selective mineralocorticoid receptor antagonist indicated for patients with chronic kidney disease associated with type 2 diabetes.
According to a recent Indian Chronic Kidney Disease (ICKD) study, diabetes is the leading cause of chronic kidney disease and end-stage kidney disease in India. Over 40 percent of all patients with diabetes will develop chronic kidney disease.
Several studies reveal that 74 million people suffer from diabetes in India, which is likely to increase to ninety-three million by 2030, making it an epidemic. India’s number of people with diabetes is the second highest in the world, after China.
“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,” Manoj Saxena, Managing Director, Bayer Zydus Pharma said in a statement.
Finerenone is different from 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.
Moreover, the results show that Finerenone significantly reduced the risk of ≥57% Glomerular Filtration Rate(eGFR) kidney composite outcome by 23 percent on top of optimised Renin-angiotensin system (RAS) blockade, and significantly reduced the risk of the composite CV outcome by 14 percent, the company stated on Thursday.
Based on the results of the clinical trials studies in July this year, Finerenone was approved by the U.S. Food and Drug Administration (FDA). It was further granted marketing authorization by the European Commission in February this year, and subsequently approved in India by the health authority in April this year.
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).