Sun Pharmaceutical Industries and Bayer have signed an agreement to market and distribute a second brand of Finerenone in India. Finerenone is indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalisation for heart failure in adult patients with chronic kidney disease associated with type 2 diabetes mellitus.
Under the terms of the agreement, Bayer has granted the non-exclusive rights to Sun Pharma to market and distribute a second brand of Finerenone under the brand name Lyvelsa. Finerenone was first launched by Bayer under the brand name Kerendia in 2022.
Finerenone 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).
The Phase III clinical trial program of Finerenone shows that it significantly reduced the risk of ≥57 per cent Glomerular Filtration Rate (eGFR) kidney composite outcome by 23 per cent on top of optimised Renin-angiotensin system (RAS) blockade, Finerenone significantly reduced the risk of the composite CV outcome by 14 per cent.
Based on the results of the clinical trial studies, Finerenone was approved by the US Food and Drug Administration (USFDA) in July 2021, further granted marketing authorisation by the European Commission in February 2022, and subsequently approved in India by the health authority in April 2022.