India’s drug regulator approves Boehringer Ingelheim’s cardiac treatment

INDIA – Global pharmaceutical company, Boehringer Ingelheim 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 enhances Jardiance’s relevance in heart-failure care.

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 entire ejection fraction spectrum.

Heart failure is a chronic condition that occurs when the heart is unable to pump enough blood to the rest of the body.

Heart failure with preserved ejection fraction (HFpEF) is a type of heart failure in which the heart muscle contracts normally but the left ventricle does not fill with enough blood, resulting in less blood entering the heart than in a normal functioning heart.


Heart failure 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.

“HFpEF occurs more commonly in older age, female gender, in people who have long-standing hypertension, type-2 diabetes mellitus, chronic kidney disease or ischemic heart disease,” said Dr Shraddha Bhure, Medical Director, Boehringer Ingelheim India.

Jardiance received approval for the new indication based on the EMPEROR-Preserved trial, which found that empagliflozin (10 mg) reduces the risk of hospitalization for heart failure and cardiovascular death by 21% in adult patients with mildly reduced or preserved ejection fraction and diabetes.

Jardiance provided significant and meaningful benefits in heart failure patients with mildly reduced as well as preserved ejection fraction.

The new indication approval applies to all eligible patients with HFpEF, regardless of type 2 diabetes status, and is in addition to the previously approved indications for type 2 diabetes glycemia control.

In addition, the treatment helps in reducing the risk of cardiovascular death plus hospitalization in adults with heart failure with reduced ejection fraction (HFrEF).

The FDA approved empagliflozin 10 mg in February 2022 to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure.

Jardiance (empagliflozin) was approved as the first and only treatment in Europe for adults with symptomatic chronic heart failure regardless of ejection fraction in March 2022.

Jardiance is not recommended for people with type 1 diabetes because it increases the risk of diabetic ketoacidosis.

Its closest competitor is AstraZeneca’s Farxiga (dapagliflozin), which reached a clinically meaningful and statistically significant reduction in the primary composite endpoint of cardiovascular (CV) death or worsening heart failure (HF), in DELIVER Phase III trial.

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