Bayer has officially announced the expansion of the indication for its drug Kerendia (finerenone) in India to include the treatment of adult patients with heart failure with preserved and mildly reduced ejection fraction (HFpEF/HFmrEF). This makes India the second country after the United States to have access to the expanded use of the drug for this specific heart failure condition.

The expanded approval allows Kerendia to be prescribed to heart failure patients with a left ventricular ejection fraction (LVEF) of 40% or more, addressing a significant unmet need as this condition previously had limited treatment options.

This new indication builds on the drug's existing approval in India (received in April 2022) for the treatment of chronic kidney disease (CKD) associated with type 2 diabetes (T2D). The approval is based on positive data from the global Phase III FINEARTS-HF study, which demonstrated a significant reduction in the risk of cardiovascular death and total heart failure events.

Shweta Rai, Managing Director - India and Country Division Head - South Asia, Bayer’s Pharmaceutical Division, said, “Our focus is on bringing breakthrough therapies to Indian patients faster, in areas where the unmet medical need is the greatest. 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.”

Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist that blocks MR overactivation - a key driver of inflammation and fibrosis in both the heart and the kidney. By targeting this pathway, it provides dual organ protection and is the only therapy proven to deliver consistent benefits across chronic kidney disease linked to type 2 diabetes as well as heart failure with preserved or mildly reduced ejection fraction.

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.