Category: Approval/Launch Region: Asia · India Company: Boehringer Ingelheim India Pvt Ltd

CDSCO approves German pharma firms drug to help reduce cardiovascular deaths in India

CDSCO approves German pharma firms drug to help reduce cardiovascular deaths in India
Jardiance is the first SGLT2-inhibitor therapy to prove reduction in risk of cardiovascular death in people with type-II diabetes and established cardiovascular disease. Jardiance or Empagliflozin is the first SGLT2-inhibitor therapy to prove reduction in risk of cardiovascular death in people with type-II diabetes and established cardiovascular disease. The drug will reduce the risk of cardiovascular death plus hospitalisation for heart failure in adults with heart failure and reduced ejection fraction (HFrEF), the company said in a statement. 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 than a normally functioning heart. Jardiance received approval from the US Food and Drug Administration (FDA) earlier this year in August for the heart failure indication. This new indication approval applies to eligible patients with HFrEF, regardless of their type-II diabetes status, and is an addition to the previously-approved indications for glycemic control in type-II diabetes, as well established cardiovascular disease, the company said.

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