Drug to treat kidney disease in India at 1/15th of US price
German firm Bayer is bringing to India a drug to treat chronic kidney disease associated with diabetes patients and costing one-fifteenth of the price in the US.
Brand named Kerendia (Finerenone) will cost Rs 97.5 per day. “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. Over 40% of all patients with diabetes will develop chronic kidney disease. 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 epidemic,” Bayer said.
After China, India has the second highest number of diabetes patients in the world. Bayer is bringing this drug to India within a year of launching it in the US.
“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 disease,” said Manoj Saxena, Managing Director, Bayer Zydus Pharma.
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 composite cardiovascular outcome by 14 percent.
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.