Bayer Expands Indication of Kerendia™ in India to Address Unmet Needs in Heart Failure Care
Bengaluru: Bayer has announced the expansion of its innovative therapy Kerendia™ (finerenone) in India to include the treatment of adult patients with heart failure with preserved and mildly reduced ejection fraction (HFpEF/HFmrEF). This new approval builds on finerenone’s existing indication for chronic kidney disease (CKD) associated with type 2 diabetes (T2D), approved in India in 2022.
Heart failure affects an estimated 1.3 to 22.7 million people in India, with nearly half of these patients living with HFpEF—a condition marked by stiff heart muscles and impaired filling despite normal pumping function. Diagnosis is often delayed due to overlapping symptoms and limited access to advanced testing, while treatment options have remained scarce.
Finerenone, a first-in-class non-steroidal, selective mineralocorticoid receptor antagonist (MRA), is the only therapy proven to reduce the risk of cardiovascular death and total heart failure events by 16% in Phase III trials, while also offering kidney protection. The latest approval is based on data from the FINEARTS-HF trial involving over 6,000 patients across 37 countries. The trial demonstrated significant reductions in cardiovascular events and improvements in patient-reported outcomes. These findings were further validated by the FINE-HEART pooled analysis of over 13,000 patients across three global studies.
“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,” said Shweta Rai, Managing Director – India and Country Division Head – South Asia, Bayer’s Pharmaceutical Division. “This reinforces our commitment to reimagining cardiovascular care and improving patient outcomes in India.”
Finerenone’s dual organ protection stems from its ability to block MR overactivation—a key driver of inflammation and fibrosis in both the heart and kidneys. It is already approved for HFpEF/HFmrEF in the United States, with regulatory submissions underway in the EU, Japan, and China.
In India, finerenone has seen strong uptake since its 2022 launch for CKD associated with T2D, a condition that can progress to kidney failure requiring dialysis or transplant. By slowing disease progression, finerenone helps reduce the physical, emotional, and economic burden on patients and families.
This latest approval marks a significant step forward in addressing India’s dual burden of cardiovascular and kidney diseases, offering new hope for patients with limited treatment options.
