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Boehringer Ingelheim gets CDSCO nod for Jardiance to treat for new heart failure indication

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German drug maker Boehringer Ingelheim (BI) on Thursday said it has received approval from the Central Drugs Standard Control Organisation (CDSCO) to market its drug Jardiance (empagliflozin) in India, for the full spectrum of heart failure diseases regardless of ejection fraction.

Jardiance is the top selling drug of BI in India, used in treatment of type-2 diabetes and for the treatment of heart failure with reduced ejection fraction (HFrEF).

The latest approval by CDSCO is for the treatment of heart failure with preserved ejection fraction (HFpEF).

“Heart failure is a chronic condition that affects nearly 1% of India’s adult population. Out of the various forms of heart failure, HFpEF accounts for nearly 20% of the cases, despite being significantly underdiagnosed,” said Dr Shraddha Bhure, medical director, Boehringer Ingelheim India.

“HFpEF occurs more commonly in older age, female gender, in people who have long-standing hypertension, type-2 diabetes mellitus, chronic kidney disease or ischaemic heart disease. At Boehringer Ingelheim, we have been working towards developing therapies to improve overall health outcomes and address unmet patient needs,” Bhure added.

Heart failure is a chronic condition in which the heart is unable to pump sufficient blood to the rest of the body. HFpEF is a form of heart failure which occurs when the heart muscle contracts normally but the left ventricle does not fill up with enough blood, leading to less blood entering the heart compared to a normal functioning heart.

BI said Jardiance received approval for the new indication based on the EMPEROR-Preserved trial which revealed that empagliflozin (10 mg) reduces the risk of hospitalization for heart-failure and cardiovascular death by 21 percent, in adult patients of heart failure with mildly-reduced or preserved ejection fraction, with or without diabetes.

“The benefits with Jardiance were demonstrated to be significant and meaningful, in patients of heart failure with mildly-reduced as well as preserved ejection fraction,” the company said.

Credits – Source – https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/boehringer-ingelheim-gets-cdsco-nod-for-jardiance-to-treat-for-new-heart-failure-indication/articleshow/91671152.cms

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