Boehringer Ingelheim announced on Thursday that it has received approval from the Central Drugs Standard Control Organisation (CDSCO) to market its innovator drug Jardiance® (empagliflozin) in India, for the treatment of heart failure with preserved ejection fraction (HFpEF). According to the pharma major’s press statement, this new indication-approval further enhances the relevance of Jardiance® in heart failure care.
“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,” the company claimed on Thursday.
“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. 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. 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,” Dr Shraddha Bhure, Medical Director, Boehringer Ingelheim India, said in a statement on Thursday.
When the heart is unable to pump sufficient blood to the rest of the body it leads to a chronic condition known as Heart Failure. 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 normally functioning heart.
According to the pharma company, 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 with heart failure with mildly-reduced or preserved ejection fraction, with or without diabetes. The company claims that the benefits with Jardiance® were demonstrated to be significant and meaningful, in patients with 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),” the company said in its press statement.
In February this year, the U.S. Food and Drug Administration (FDA) approved empagliflozin 10 mg to reduce the risk of cardiovascular death and hospitalisation for heart failure in adults with heart failure. In March this year, Jardiance® (empagliflozin) became the first and only approved treatment in Europe for adults with symptomatic chronic heart failure regardless of ejection fraction. However, Jardiance® is not recommended for people with type 1 diabetes as it may increase the risk of diabetic ketoacidosis in these patients. The company also cautioned that to find out about the eligibility of a patient for receiving any treatment, the managing doctor’s advice and guidance should be followed.