Bayer announced a major expansion of its innovative therapy, Kerendia™ (finerenone), in India, now approved for the treatment of adult patients with heart failure with preserved ejection fraction (HFpEF) and mildly reduced ejection fraction (HFmrEF). This follows its previous approval in 2022 for chronic kidney disease (CKD) associated with type 2 diabetes (T2D), where it has already shown benefits in slowing kidney disease progression and reducing cardiovascular risk.

Heart failure (HF), distinct from a heart attack, is a chronic and serious condition where the heart cannot pump blood efficiently to meet the body’s needs, resulting in symptoms like fatigue, shortness of breath, and fluid accumulation. India faces a significant burden, with an estimated 1.3 million to 22.7 million affected, nearly half of whom have HFpEF/HFmrEF. Diagnosing these types remains challenging, often leading to delayed treatment, while proven therapies have been limited.

Finerenone is the first and only non-steroidal, selective mineralocorticoid receptor antagonist (MRA) shown in Phase III studies to reduce the risk of cardiovascular death and total heart failure events by 16%, while providing kidney protection. The recent approval is based on the positive outcomes from the FINEARTS-HF Phase III trial involving over 6,000 patients in 37 countries, supported by pooled analyses from over 13,000 patients worldwide.

Shweta Rai, Managing Director of Bayer’s Pharmaceutical Division in India, stated, “With the expanded approval of finerenone, Bayer continues to address unmet needs in India’s cardiovascular landscape, delivering innovation for conditions with the greatest clinical gaps.”

Finerenone’s proven efficacy in HFpEF/HFmrEF and CKD associated with T2D marks a significant milestone for comprehensive cardiovascular and kidney care in India, offering hope for improved patient outcomes and quality of life. The therapy is already approved for HFpEF/HFmrEF in the US and under review in other major markets.