San Sebastian (Spain): Pharmaceutical major Bayer has filed for approval to market its patented drug finerenone in India for treating certain heart failure patients, a potential boost in a country increasingly grappling with early onset of heart disease.
Finerenone, branded as Kerendia, received USFDA approval in July 2025 for treatment of heart failure with a left ventricular ejection fraction (LVEF). At present, finerenone is approved in India for treatment of chronic kidney disease (CKD) with type 2 diabetes. Besides Kerendia, Sun Pharma markets a second brand of finerenone, Lyvelsa, through an agreement with Bayer.
"The drug has been there for almost three years for chronic kidney disease for patients with diabetes," said Ashraf Al-Ouf, head of commercial operations, Asia Pacific, at Bayer Pharmaceuticals division. "For heart failure, we just finished the study and the result was very good. It's going through approval now with the authorities."
The medicine is under review for approval for treatment of heart failure patients with LVEF of 40 and above. "This is for patients who are diagnosed with heart failure, so that it doesn't get worse," Al-Ouf said.
It is predicted that by 2050, heart failure cases in Asia Pacific will reach 74.5 million, a 127.6% increase from 2025.
"Amid these concerning projections, we are poised to address healthcare needs and bring new therapeutic options for patients across East Asia, South Asia, Southeast Asia and Oceania," Al-Ouf said.
Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA) and the first drug targeting the mineralocorticoid receptor (MR) pathway that has demonstrated cardiovascular benefits in patients.
Al-Ouf said Bayer expects approval in India for the new indication by the end of the year. The trials in India started last year. "A big number of patients (in trials) were from India. The message is, we have really increased involvement of India because the pathway is good, the reliability is good, the quality of the data is also good," he said.
(The reporter is in Spain on Bayer's invitation.)
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Finerenone, branded as Kerendia, received USFDA approval in July 2025 for treatment of heart failure with a left ventricular ejection fraction (LVEF). At present, finerenone is approved in India for treatment of chronic kidney disease (CKD) with type 2 diabetes. Besides Kerendia, Sun Pharma markets a second brand of finerenone, Lyvelsa, through an agreement with Bayer.
"The drug has been there for almost three years for chronic kidney disease for patients with diabetes," said Ashraf Al-Ouf, head of commercial operations, Asia Pacific, at Bayer Pharmaceuticals division. "For heart failure, we just finished the study and the result was very good. It's going through approval now with the authorities."
The medicine is under review for approval for treatment of heart failure patients with LVEF of 40 and above. "This is for patients who are diagnosed with heart failure, so that it doesn't get worse," Al-Ouf said.
It is predicted that by 2050, heart failure cases in Asia Pacific will reach 74.5 million, a 127.6% increase from 2025.
"Amid these concerning projections, we are poised to address healthcare needs and bring new therapeutic options for patients across East Asia, South Asia, Southeast Asia and Oceania," Al-Ouf said.
Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA) and the first drug targeting the mineralocorticoid receptor (MR) pathway that has demonstrated cardiovascular benefits in patients.
Al-Ouf said Bayer expects approval in India for the new indication by the end of the year. The trials in India started last year. "A big number of patients (in trials) were from India. The message is, we have really increased involvement of India because the pathway is good, the reliability is good, the quality of the data is also good," he said.
(The reporter is in Spain on Bayer's invitation.)
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