Bayer today announce the launch of Finerenone under the brand name KerendiaTM in India. Finerenone is a first-in-class non-steroidal, selective mineralocorticoid receptor antagonist indicate for patients with chronic kidney disease associate 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, Said :
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 associate 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%
Base on the results of the clinical trials studies, Finerenone was approve 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 approve in India by the health authority in April 2022.
As per the approval in India, Finerenone is indicate to reduce the risk of sustained Estimate 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) associate with type 2 diabetes (T2D.)
5. Bakris GL, et al. N Engl J Med 2020. doi: 10.1056/NEJMoa2025845; Pitt B, et al. N Engl J Med 2021; doi: 10.1056/NEJMoa2110956
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