In a significant development for the Indian healthcare sector, Sun Pharmaceutical Industries Limited and Bayer have announced a collaborative agreement to market and distribute a second brand of Finerenone in India. This move is set to revolutionize the treatment landscape for chronic kidney disease (CKD) associated with type 2 diabetes mellitus (T2DM).

Finerenone: A Game-Changer in Diabetes-related CKD Treatment

Finerenone, a patented medication, is designed to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with CKD associated with T2DM. Bayer first introduced Finerenone in India in August 2022 under the brand name Kerendia™. With this new agreement, Sun Pharma will market the drug under the brand name Lyvelsa.

India’s Diabetes and Kidney Disease Challenge

The Indian Chronic Kidney Disease study highlights diabetes as the leading cause of CKD and end-stage kidney disease in India. Over 40% of diabetes patients develop CKD, and with more than 100 million people in India suffering from diabetes, the disease is an epidemic. The existing treatment options often fall short in preventing kidney failure and premature death in these patients.

Unique Mechanism of Finerenone

Finerenone stands out from other CKD treatments for T2D patients by selectively blocking mineralocorticoid receptor overactivation, a key factor in CKD progression and cardiovascular damage. The 2023 American Diabetes Association guideline endorses Finerenone for its ability to improve cardiovascular outcomes and reduce CKD progression.

Clinical Trials and Global Approvals

The efficacy and safety of Finerenone have been validated through a pivotal Phase III clinical trial program involving over 13,000 patients globally. The trials demonstrated significant reductions in kidney and cardiovascular risks. Following these results, Finerenone received approval from the U.S. FDA in July 2021, the European Commission in February 2022, and the Indian health authority in April 2022.

Statements from Industry Leaders

Shweta Rai, Country Division Head for Bayer’s Pharmaceuticals Business in South Asia, commented on the partnership: “With the introduction of a second brand of Finerenone in India, through our partnership with Sun Pharma, we are advancing Bayer’s commitment to making healthcare accessible to as many patients as possible…”

Kirti Ganorkar, CEO – India Business, Sun Pharma, also expressed enthusiasm: “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. This partnership underscores our commitment to make innovative medicines available to patients in India.”

This strategic partnership between Bayer and Sun Pharma marks a significant milestone in providing advanced and accessible treatment options for CKD patients in India.

  Bayer, chronic kidney disease, Diabetes, Finerenone, Kerendia, Kirti Ganorkar, Lyvelsa, Shweta Rai, Sun Pharma