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Bayer’s innovative therapy Kerendia (finerenone) has received approval in India for the treatment of adult patients with heart failure with a preserved and mildly reduced ejection fraction (HFpEF/HFmrEF). This builds on finerenone’s existing approval received in India in 2022 for chronic kidney disease (CKD) associated with type 2 diabetes (T2D), where it has already been proven to slow kidney disease progression and reduce 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) unlike a heart attack which is a sudden event, is a chronic condition in which the heart cannot pump enough blood to meet the body’s needs, leading to fatigue, breathlessness and fluid buildup Nearly half of these patients live with preserved or mildly reduced ejection fraction (HFpEF/HFmrEF), which is one type of HF in which the heart’s pumping function appears normal, but the muscle is stiff and filling is impaired.
HFpEF is diagnosed through a combination of clinical assessment, echocardiography and advanced blood tests like biomarkers. As a result of delayed diagnosis and limited innovations, patient care in HFpEF/HFmrEF has been restricted to symptom control and management of comorbidities, leaving a significant unmet need in cardiovascular care.
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. These findings were further reinforced by the FINE-HEART pooled analysis, which included data from over 13,000 patients across three global Phase III programs, confirming finerenone as the only therapy with consistent kidney and cardiovascular benefits across high-risk populations.
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