Bayer is rolling out Kerendia, its oral drug to treat people with chronic kidney disease (CKD), and the India launch comes a little over a year after the drug was approved in the US.
With about 40 per cent of people with Type II Diabetes estimated to get CKD, the drug adds to the doctor’s toolkit to manage the disease as it slows down its progression, said top executives with the company.
Bayer’s Finerenone, sold under the brandname Kerendia, is priced at ₹97 per pill, and needs to be taken once a day, Manoj Saxena, Managing Director, Bayer Zydus Pharma told BusinessLine, and the India-specific pricing is one-fifteenth the global price. Kerendia is being imported from Germany and sold in India through the existing Bayer Zydus joint venture, he added
CKD is an “under recognised and under diagnosed” disease that silently progresses, said Saxena. Clinical trials on the drug before it was launched, was done in a diverse population that included Indians, he added.
Finerenone is the first non-steroidal, selective mineralocorticoid receptor antagonist to show significant reduction in the risk of kidney and heart problems in CKD patients with Type II diabetes. While CKD can develop for other reasons as well, diabetes is a leading cause according to studies. And India is home to about 74 million people living with diabetes, second to China.
Pointing out that Kerendia offers a new treatment approach for vulnerable patients, he said, it slows down the progression of CKD and reduces the risk of kidney failure. It can also reduce the risk of heart disease associated with CKD, he added.
Outlining details of other ongoing trials, Dr Ashish Gawde, Country Medical Director, said the drug’s benefits are also being assessed in a non-diabetic group and among those with heart ailments.
The pivotal Phase III clinical trial program of Finerenone involved more than 13000 patients globally and was undertaken to investigate the safety and efficacy of kidney and cardiovascular outcomes in patients with CKD and type 2 diabetes, the company said.
Finerenone was approved by the US Food and Drug Administration in July 2021, and marketing authorization by the European Commission in February 2022. Regulatory approvals in India came in April 2022.