The Central Drugs Standard Control Organisation has approved German drugmaker Boehringer Ingelheim's type-2 diabetic drug Jardiance (Empagliflozin) for marketing in India. Here's what you should know about it.
German drugmaker Boehringer Ingelheim on Monday announced that it had received approval to market Jardiance (Empagliflozin), a type-2 diabetes medication, in the Indian market. This decision was approved by the Central Drugs Standard Control Organisation (CDSCO).
The medicine was approved upon the indication that it can reduce the risk of heart failure in adults. This is an addition to the previously approved indications for glycemia control, as well as restraining cardiovascular disease/death in type-2 diabetes.
As per Financial Express, 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 the standard of care in a broad range of 3,730 adults with and without Type-2 diabetes who had heart failure and a left ventricular ejection fraction of 40 per cent or less.
The trial also involved 150 patients from India, in whom the results were consistent with the overall findings, reports stated.
The US Food and Drug Administration (USFDA) had earlier approved the drug for its heart failure indication in August 2021. On the approval, Javed Butler, MD and chairman of the Department of Medicine, University of Mississippi had said, “Heart failure is a chronic, debilitating cardio-renal-metabolic condition affecting over 60 million people worldwide. As the prevalence of heart failure continues to rise, the need for new treatment options is critical.”
“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 make 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,” said Dr Shraddha Bhure, Medical Director of Boehringer Ingelheim India in a press release.
Here’s some things to know about the drug:
- The new indication approval applies to eligible patients of heart failure with reduced ejection fraction (HFrEF), which accounts for more than half of heart failure cases.
- Jardiance became the first SGLT2-inhibitor therapy to cut the risk of cardiovascular death in people with type 2 diabetes and established cardiovascular disease, as per Economic Times.
- 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.
Jardiance 25mg tablet costs Rs 62.2/tablet in India.
(Edited by Divya Sethu)