Boehringer Ingelheim Obtains Drug Regulator Approval to Market Cardiac Drug in India

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

Following Jardiance’s previous approval for the treatment of heart failure with reduced ejection fraction (HFrEF), this new indication approval further reinforces Jardiance’s relevance in the treatment of heart failure, the company said. in a press release.

The company said that with this approval, Jardiance is now the first and only treatment clinically approved to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure across the spectrum of heart failure. ejection fraction. Heart failure is a chronic disease in which the heart is unable to pump enough blood to the rest of the body. HFpEF is a form of heart failure that occurs when the heart muscle contracts normally but the left ventricle does not fill with enough blood, resulting in less blood entering the heart compared to a normally functioning heart.

“Heart failure is a chronic disease that affects almost 1% of the Indian adult population. Among the different forms of heart failure, HFpEF accounts for nearly 20% of cases, although it is significantly underdiagnosed. HFpEF occurs more frequently in older people, females, people with long standing hypertension, type 2 diabetes mellitus, chronic kidney disease or ischemic heart disease,” said Dr Shraddha Bhure, medical director of Boehringer Ingelheim India.

“At Boehringer Ingelheim, we have worked to develop therapies to improve overall health outcomes and address unmet patient needs. With the approval of the additional indication and Jardiance now the first treatment approved to treat the full spectrum of heart failure, regardless of ejection fraction, Boehringer Ingelheim has achieved another major healthcare milestone. heart,” she said.

Jardiance has received approval for the new indication based on the EMPEROR-Preserved trial which found that empagliflozin (10 mg) reduced the risk of heart failure hospitalization and cardiovascular death by 21%, in adult patients with heart failure with mildly reduced or preserved heart failure. ejection fraction, with or without diabetes. The benefits of Jardiance have been shown to be significant and significant in patients with heart failure with mildly reduced ejection fraction as well as preserved ejection fraction.

The approval of the new indication applies to eligible patients with HFpEF, regardless of type 2 diabetes status, and is in addition to previously approved indications for glycemic control in type 2 diabetes, as well as to reduce the risk of cardiovascular death and hospitalization for adults with heart failure with reduced ejection fraction (HFrEF).

In February 2022, the United States 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 because it may increase the risk of diabetic ketoacidosis in these patients. 4 With respect to a patient’s eligibility for treatment, the advice and guidance of the treating physician should be followed.

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