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Sun Pharmaceutical Industries and Bayer have signed an agreement to market and distribute a second brand of Finerenone in India. The patented drug is used to treat chronic kidney disease associated with Type-2 diabetes mellitus.
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Bayer has granted Sun Pharma non-exclusive rights to market and distribute this brand of Finerenone under the brand name Lyvelsa, in India. Finerenone was first launched by Bayer under the brand name Kerendia (2022).
Kirti Ganorkar, Sun Pharma’s Chief Executive (India Business), said, the collaboration “would provide patients access to a new treatment, which slows down the progression of chronic kidney disease and reduces the risk of kidney failure associated with Type-2 diabetes.” Shweta Rai, Country Division Head, Bayer Pharmaceuticals (South Asia) pointed out that India has a high incidence of diabetes and associated renal and cardiac conditions.
In a joint statement, the companies cited a study by the Indian Chronic Kidney Disease (ICKD) that identified diabetes as 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, it said. Over 100 million people have diabetes in India, home to the second largest affected population after China.
Despite available treatment options, many patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) progress to kidney failure and premature death, the note said. Finerenone is different from the existing treatments for CKD in T2D patients, in that it acts “by selectively blocking mineralocorticoid receptor (MR) overactivation, which is thought to contribute to CKD progression and cardiovascular damage. “
The pivotal Phase III clinical trial programme 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. Finerenone was approved by the US Food and Drug Administration in July 2021; it received marketing authorization from the European Commission in February 2022, and was subsequently approved in India by the regulators in April 2022, the note said.
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