German pharma major Bayer has received Indian drug regulator’s approval to market its innovative therapy Kerendia (finerenone) for the treatment of adult patients with heart failure. Finerenone is already approved in the country for the treatment of chronic kidney disease (CKD) associated with type 2 diabetes (T2D), where it has proven to slow kidney disease progression and reduce cardiovascular risk.

“With the expansion of finerenone’s indication, we are addressing types of heart failure that account for nearly half of all heart failure cases but have had limited proven treatment options. Together with its role in chronic kidney disease linked to type 2 diabetes, finerenone represents Bayer’s innovation against India’s most pressing health burdens such as cardiovascular disease and chronic kidney disease, strengthening our commitment to reimagining cardiovascular care and improving patient outcomes in the country” Shweta Rai, Managing Director - India and Country Division Head - South Asia, Bayer’s Pharmaceutical Division, said.

Unlike a heart attack which is a sudden event, heart failure is a chronic condition in which the heart cannot pump enough blood to meet the body’s needs, leading to fatigue, breathlessness and fluid build up. It is a growing concern in India, with prevalence estimates ranging from 1.3 million to 22.7 million people, and between 0.5 to 1.8 million new cases diagnosed each year.

The approval in India is based on data from the FINEARTS-HF Phase III trial, which enrolled more than 6,000 patients across 37 countries. Results demonstrated a 16% reduction in the composite risk of cardiovascular death and total heart failure events, alongside significant improvements in patient-reported health status.

Finerenone is already approved in India for CKD associated with T2D, where it has demonstrated strong patient uptake since its launch in India in 2022. It has been one of the key growth drivers for Bayer’s global CKD portfolio.

Chronic kidney disease (CKD) is a long-term condition in which the kidneys gradually lose their ability to filter waste and excess fluid from the blood, leading to toxin buildup. This can progress to kidney failure where dialysis or kidney transplant is the only treatment option. Finerenone helps to halt the progression of CKD and reduces the need for dialysis or transplant, easing the economic, physical and emotional burden on patients and families.

Launched in India in August 2022 for the treatment of chronic kidney disease (CKD) associated with type 2 diabetes, Kerendia is priced at approximately one dollar a day across dosage strengths, ensuring accessibility for patients while maintaining global quality standards. The expanded indication doesn't affect the price, it's the same drug and price, now helping a wider patient group.

According to official sources, Kerendia, which witnessed 100% growth in market share in India last year, has been one of the biggest launches for Bayer in India and still features among the top launches in the last three years in the Indian pharma industry.

The CKD market in India currently stands at $556.5 crore with an 18% growth rate, while the heart failure (HF) market is valued at $2,037.2 crore, growing at 17%. The expanded indication for Kerendia in heart failure with preserved and mildly reduced ejection fraction (HFpEF/HFmrEF) is expected to significantly broaden its patient reach within this fast-growing therapeutic area.