India Pharma Outlook Team | Friday, 07 November 2025
Bayer announced that its 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. It is a growing concern in India, with prevalence estimates ranging from 1.3 million to 22.7 million people, and between 0.5 to 1.8 million new cases diagnosed each year. National registry data show that Indian patients develop cardiovascular diseases nearly a decade earlier than in high-income countries and face high rates of hospitalisation and mortality. 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. In this type of HF, mortality and hospitalizations remain a real threat to patients. 1 in 5 are re-hospitalized within 30 days of discharge. Every hospitalization doubles the mortality risk.
HFpEF is diagnosed through a combination of clinical assessment, echocardiography and advanced blood tests like biomarkers. The diagnosis is often difficult because patients don’t show clear changes on routine heart tests, symptoms such as breathlessness, fatigue, swelling in the legs and ankles and reduced exercise tolerance can be confused with other conditions, and advanced blood tests are not always available. 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.
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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 (FIDELIO-DKD, FIGARO-DKD, FINEARTS-HF), confirming finerenone as the only therapy with consistent kidney and cardiovascular benefits across high-risk populations.
Finerenone is already approved for HFpEF/HFmrEF in the United States and submissions are under review in the EU, Japan and China, with further applications pending worldwide.
Finerenone is already approved in India for CKD associated with T2D, where it has demonstrated strong patient uptake since its launch in India in 2022. It has been one of the key growth drivers for Bayer’s global CKD portfolio.
Chronic kidney disease (CKD) is a long-term condition in which the kidneys gradually lose their ability to filter waste and excess fluid from the blood, leading to toxin buildup. This can progress to kidney failure where dialysis or kidney transplant is the only treatment option. finerenone helps to halt the progression of CKD and reduces the need for dialysis or transplant, easing the economic, physical and emotional burden on patients and families.
