Bayer’s Kerendia™ receives Indian approval for treating heart failure….

Bayer’s Kerendia™ receives Indian approval for treating heart failure

Kolkata, 6th November 2025: Bayer today announced that its innovative therapy Kerendia™ (finerenone) has received approval in India for treating adult patients with heart failure with preserved and mildly reduced ejection fraction (HFpEF/HFmrEF). This expands finerenone’s earlier approval (in 2022) for chronic kidney disease (CKD) linked to type 2 diabetes (T2D), where it has already demonstrated benefits in slowing kidney disease progression and reducing cardiovascular (CV) risk.

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.”

Heart failure (HF) is a chronic condition where the heart fails to pump enough blood to meet the body’s needs, causing fatigue, breathlessness, and fluid buildup. In India, 1.3 to 22.7 million people are affected, with up to 1.8 million new cases annually. Nearly half live with HFpEF/HFmrEF, where the heart’s pumping appears normal but its stiffness limits function, increasing hospitalization and death risks.

Finerenone, a non-steroidal, selective mineralocorticoid receptor antagonist (MRA), blocks MR overactivation—key to inflammation and fibrosis in both heart and kidney—providing dual-organ protection.

The approval follows results from the FINEARTS-HF Phase III trial involving over 6,000 patients across 37 countries, which showed a 16% reduction in cardiovascular death and heart failure events. Finerenone is already approved for HFpEF/HFmrEF in the U.S., with reviews ongoing in the EU, Japan, and China.