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 hospitalization for heart failure in adults with heart failure, across the full spectrum of ejection fraction.

Dr Shraddha Bhure, Medical Director, Boehringer Ingelheim India, said, “Heart failure is a chronic condition that affects nearly 1% of India’s adult population. Out of the various forms of heart failure, HFpEF accounts for nearly 20% of the cases, despite being significantly underdiagnosed. HFpEF occurs more commonly in older age, female gender, in people who have long-standing hypertension, type-2 diabetes mellitus, chronic kidney disease or ischaemic heart disease. 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.”

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 hospitalization for adults with heart failure with reduced ejection fraction (HFrEF).

In February 2022, the U.S. Food and Drug Administration (FDA) approved empagliflozin 10 mg to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. In March 2022, Jardiance (empagliflozin) became the first and only approved treatment in Europe for adults with symptomatic chronic heart failure regardless of ejection fraction.