New Delhi, Nov 22 (PTI) Global pharmaceuticals major Boehringer Ingelheim on Monday said it has received approval from India’s Central Drugs Standard Control Organisation (CDSCO) to market its innovator cardiovascular drug Jardiance (empagliflozin) for indication in heart failure and reduced ejection fraction (HFrEF).
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.
This new indication approval applies to eligible patients with HFrEF, regardless of their type-2 diabetes status, Boehringer Ingelheim said in a statement.
It 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, the company added.
Commenting on the approval, Boehringer Ingelheim India Medical Director Shraddha Bhure said evidence from India suggests earlier age of onset, poor outcomes and high mortality rate due to heart failure, pointing towards the need for continuous innovation and improved therapy options.
“The approval for the additional indication for Jardiance underlines Boehringer Ingelheim’s core value of developing therapies and health care solutions in areas of unmet/lesser met medical needs,” Bhure added.
However, the company said Jardiance is not recommended for people with type-1 diabetes as it may increase the risk of diabetic ketoacidosis, a life threatening complication where the body produces excess blood acid. PTI RKL HRS hrs
