Mumbai based Sun Pharmaceutical Industries announced on Thursday that it has signed an agreement with Bayer to market and distribute Bayer’s patented drug Finerenone in India under the brand name Lyvelsa.
The patented drug is used to treat chronic kidney disease associated with Type-2 diabetes mellitus, and reduce the cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients.
As per the agreement, Sun Pharma has been granted the non-exclusive rights by Bayer to market and distribute a second brand of Finerenone. Finerenone was first launched by Bayer under the brand name Kerendia in 2022.
Finerenone was approved by the US Food and Drug Administration (USFDA) in July 2021. In February 2022, the drug was further granted marketing authorization by the European Commission. In India, Finerenone was approved by the health authority in April 2022.
“With the introduction of a second brand of Finerenone in India, through our partnership with Sun Pharma, we are advancing Bayer’s commitment of making healthcare accessible to as many patients as possible. India has a high incidence of diabetes and associated renal and cardiac conditions,” said Shweta Rai, Country Division Head for Bayer’s Pharmaceuticals Business in South Asia in a press statement.
Nearly 100 million people suffer from diabetes in India. In fact, diabetes is identified as one of the leading cause of chronic kidney diseases and end-stage kidney disease in India. According to the Indian Chronic Kidney Disease (ICKD) study, over 40 per cent of all patients with diabetes will develop chronic kidney disease.
Finerenone, according to the company’s statement, is different from the existing treatments for CKD in type 2 diabetes (T2D) patients. It acts by selectively blocking mineralocorticoid receptor (MR) overactivation, which is thought to contribute to CKD progression and cardiovascular damage. “The 2023 American Diabetes Association (ADA) guideline recommends the use of Finerenone for individuals with T2D and CKD with albuminuria treated with the maximum tolerated doses of ACE inhibitors/ARB, to improve cardiovascular outcomes and reduce the risk of CKD progression (level of recommendation A),” said the company’s statement.
Kirti Ganorkar, CEO - India Business, Sun Pharma said, “We are happy to collaborate with Bayer to 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."