INDIA – Indian drug regulator, the Drugs Controller General of India (DCGI) has given Boehringer Ingelheim permission to market Jardiance (empagliflozin) in India for an additional indication to reduce heart failure in adults.
The approval is based on the additional data indicating that the drug significantly lowers the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure and a low ejection fraction.
Heart failure is a common and serious complication of a heart attack that occurs when the heart is unable to pump enough blood to the rest of the body.
Heart failure is frequently associated with other cardio-renal-metabolic diseases, such as type 2 diabetes and kidney disease. Because these systems are interconnected, improvements in one can have a positive impact on the others.
People suffering from heart failure frequently experience shortness of breath and fatigue, which can have a negative impact on their quality of life.
The treatment of heart failure focuses on managing these underlying diseases and improving symptoms. Medications play an important role in achieving these treatment objectives.
Jardiance was approved based on the findings of the EMPEROR-Reduced phase III trial, which looked at the effect of adding Jardiance 10 mg versus placebo to standard of care in a large group of 3,730 adults with and without type 2 diabetes who had heart failure and a left ventricular ejection fraction of 40% or less.
In the study, Jardiance significantly reduced the relative risk of primary composite endpoint of time to cardiovascular death or hospitalization for heart failure by 25% compared to the placebo.
This new indication approval applies to all eligible patients with heart failure and a low ejection fraction, regardless of type-2 diabetes status.
It is an addition to the previously approved indications for type-2 diabetes glycemia control and cardiovascular death in patients with type-2 diabetes and established cardiovascular disease.
This nod came after Boehringer received USFDA approval for empagliflozin for the heart failure indication earlier this year, in August.
Empagliflozin is an inhibitor of sodium-glucose co-transporter-2 (SGLT2), the transporters primarily responsible for the reabsorption of glucose in the kidney.
It is used clinically as an adjunct to diet and exercise, in combination with other drug therapies for the management of type-2 diabetes mellitus.
Jardiance is the first type 2 diabetes treatment approved with this additional indication and the only type 2 diabetes medicine shown in a clinical trial to provide a life-saving cardiovascular benefit. The drug is marketed by Boehringer Ingelheim and Eli Lilly Company.