Boehringer Ingelheim has received approval from the Drugs Controller General of India to market its innovator drug Jardiance (empagliflozin) in India. The approval is based on the 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 US Food and Drug Administration (USFDA), 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.
Dr Shraddha Bhure, Medical Director, Boehringer Ingelheim India, said, “Heart failure is a progressive, devitalizing 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 health care 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,” he added.
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 2 diabetes who had heart failure (functional class II, III or IV) and a left ventricular ejection fraction of 40% or less.
In the trial, Jardiance significantly reduced the relative risk of the primary composite endpoint of time to cardiovascular death or hospitalization for heart failure by 25% (5.3% absolute risk reduction, 0.75 HR, 0.65-0.86 95% CI) versus placebo.3 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.
Jardiance is not recommended for people with type 1 diabetes as it may increase the risk of diabetic ketoacidosis in these patients. Regarding the eligibility of a patient for receiving any treatment, the managing doctor’s advice and guidance should be followed.