Boehringer Ingelheim has received approval from the Central Drugs Standard Control Organisation (CDSCO) to market its innovator drug Jardiance in India, for additional indication to reduce the risk of cardiovascular death plus hospitalisation for heart failure in adults with heart failure and reduced ejection fraction (HFrEF), the company notified via a statement.
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 glycemia control in type-II diabetes, as well as for cardiovascular death in patients with type-II diabetes and established cardiovascular disease, it further said.
It also said that Jardiance received approval from the US Food and Drug Administration (FDA), 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, the statement mentioned.
Dr Shraddha Bhure, Medical Director, Boehringer Ingelheim India, 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.
“The approval for the additional indication for Jardiance underlines Boehringer Ingelheim’s core value of developing therapies and healthcare solutions in areas of unmet/lesser met medical needs. Through this development, we look to making a positive difference in the lives of heart failure patients across India, thereby significantly reducing negative health, productivity and economic impact on the lives of patients and healthcare systems.”
This approval for Jardiance is based on results from the Emperor-Reduced phase-III trial, which investigated the effect of adding Jardiance 10 mg versus placebo to standard of care in a broad range of 3,730 adults with and without type-II diabetes who had heart failure (functional class II, III or IV) and a left ventricular ejection fraction of 40 per cent or less. In the trial, Jardiance significantly reduced the relative risk of the primary composite endpoint of time to 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) versus placebo. 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.