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Boehringer Ingelheim has received approval from the Central Drugs Standard Control Organisation (CDSCO) to market its innovator drug Jardiance® (empagliflozin) in India, for additional indication to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure and reduced ejection fraction (HFrEF).
This new indication approval applies to eligible patients with HFrEF, 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 cardiovascular death in patients with type-2 diabetes and established cardiovascular disease.
Jardiance® received approval from the U.S. Food and Drug Administration, earlier this year in August, for the heart failure indication.
HFrEF, which accounts for more than half of heart failure cases, occurs when the heart muscle does not contract effectively, and less blood is pumped out to the body compared with a normally functioning heart.
Jardiance® is not recommended for people with type 1 diabetes as it may increase the risk of diabetic ketoacidosis in these patients.
