Last Updated on December 31, 2023 by The Health Master
German drug maker Boehringer Ingelheim said it has won approval from the Indian drug regulator (CDSCO) to market its top-selling type-2 diabetes medication, Jardiance (empagliflozin), in India, for an additional indication to reduce the risk of heart failure in adults.
The new indication approval applies to eligible patients with HFrEF (heart failure with reduced ejection fraction), regardless of their type-2 diabetes status, and is an addition to the previously approved indications for glycemic control in type-2 diabetes, as well as for cardiovascular death in patients with type-2 diabetes and established cardiovascular disease.
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.
Jardiance received approval from the USFDA earlier this year, in August, for the heart failure indication. Jardiance became the first SGLT2-inhibitor therapy to cut the risk of cardiovascular death in people with type 2 diabetes and established cardiovascular disease. Diabetes is also linked to heart failure.
The approval for Jardiance by the CDSCO 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% versus placebo.
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.
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