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Boehringer Ingelheim gets approval from drug regulator to market its cardiac drug in India


Global pharmaceutical company Boehringer Ingelheim on Thursday announced that it has received the approval from the Central Drugs Standard Control Organisation (CDSCO) to market its innovator cardiac drug Jardiance (empagliflozin) in India.

Following the previous approval for Jardiance for the treatment of heart failure with reduced ejection fraction (HFrEF), this new indication-approval further enhances the relevance of Jardiance in heart-failure care, the company said in a statement.

The company claimed, with this approval, Jardiance is now the first and only clinically approved therapy to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure, across the full spectrum of ejection fraction. 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.

“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 per cent of the cases, despite being significantly underdiagnosed. 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,” Dr Shraddha Bhure, Medical Director, Boehringer Ingelheim India, said.

“At Boehringer Ingelheim, we have been working towards developing therapies to improve overall health outcomes and address unmet patient needs. With the approval for the additional indication and Jardiance now being the first approved therapy to treat the full spectrum of heart failure irrespective of ejection fraction, Boehringer Ingelheim has achieved another essential milestone in the area of cardiac care,” she 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 new indication approval applies to eligible patients with HFpEF, regardless of their type-2 diabetes status, and is an addition to the previously approved indications for glycemia control in type-2 diabetes, as well as for reducing the risk of cardiovascular death plus hospitalization for adults with heart failure with reduced ejection fraction (HFrEF).

In February 2022, the U.S. Food and Drug Administration (FDA) approved empagliflozin 10 mg to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. In March 2022, Jardiance (empagliflozin) became the first and only approved treatment in Europe for adults with symptomatic chronic heart failure regardless of ejection fraction.

Jardiance is not recommended for people with type 1 diabetes as it may increase the risk of diabetic ketoacidosis in these patients. 4 Regarding the eligibility of a patient for receiving any treatment, the managing doctor’s advice and guidance should be followed.

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