Boehringer Ingelheim, the German pharmaceutical company, has received approval from the Central Drugs Standard Control Organisation (CDSCO) to market its drug Jardiance in India for an additional heart failure indication.
Jardiance or Empagliflozin is the first SGLT2-inhibitor therapy to prove reduction in risk of cardiovascular death in people with type-II diabetes and established cardiovascular disease.
The drug will reduce the risk of cardiovascular death plus hospitalisation for heart failure in adults with heart failure and reduced ejection fraction (HFrEF), the company said in a statement.
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 than a normally functioning heart. Jardiance received approval from the US Food and Drug Administration (FDA) earlier this year in August for the heart failure indication.
This new indication approval applies to eligible patients with HFrEF, regardless of their type-II diabetes status, and is an addition to the previously-approved indications for glycemic control in type-II diabetes, as well established cardiovascular disease, the company said.
“Heart failure is a progressive, devitalising and potentially life-threatening condition affecting over 60 million people worldwide. 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," said Shraddha Bhure, Medical Director, Boehringer Ingelheim India.
In the trial, Jardiance significantly reduced the relative risk of cardiovascular death or hospitalisation for heart failure by 25 per cent (5.3 per cent absolute risk reduction, 0.75 HR, 0.65-0.86 95% CI). These results were seen early and were consistent regardless of the diabetes status, or background standard of care treatments for heart failure. The study also involved 150 patients from India, in whom the results were consistent with the overall findings, said the statement.
This approval for Jardiance is based on results from the Emperor-Reduced phase-III trial, which investigated the effect of adding Jardiance 10 mg to a standard of care of 3,730 adults with and without type-II diabetes who had heart failure and a left ventricular ejection fraction of 40 per cent or less.
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