The drug is the first treatment for heart failure with preserved ejection fraction (HFpEF) in India
Boehringer Ingelheim has received approval from the Central Drugs Standard Control Organisation (CDSCO) to market its innovator drug Jardiance (empagliflozin) in India, for the treatment of heart failure with preserved ejection fraction (HFpEF). Following the previous approval for Jardiance for the treatment of heart failure with reduced ejection fraction (HFrEF), this new indication-approval further enhances the relevance of Jardiance in heart-failure care. With this approval, Jardiance is now the first and only clinically approved therapy to reduce the risk of cardiovascular death plus hospitalisation for heart failure in adults with heart failure, across the full spectrum of ejection fraction.
Dr Shraddha Bhure, Medical Director, Boehringer Ingelheim India, said, “ At Boehringer Ingelheim, we have been working towards developing therapies to improve overall health outcomes and address unmet patient needs. With the approval for the additional indication and Jardiance now being the first approved therapy to treat the full spectrum of heart failure irrespective of ejection fraction, Boehringer Ingelheim has achieved another essential milestone in the area of cardiac care.”
Jardiance received approval for the new indication based on the EMPEROR-Preserved trial that revealed that empagliflozin (10 mg) reduces the risk of hospitalisation for heart-failure and cardiovascular death by 21 per cent, in adult patients of heart failure with mildly-reduced or preserved ejection fraction, with or without diabetes. The benefits with Jardiance were demonstrated to be significant and meaningful, in patients of heart failure with mildly-reduced as well as preserved ejection fraction.
The new indication approval applies to eligible patients with HFpEF, 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 reducing the risk of cardiovascular death plus hospitalisation for adults with heart failure with reduced ejection fraction (HFrEF).
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.
