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US Regulatory Authorities Approve New Drug To Treat Patients With High Cholesterol

by Shirley Johanna on  July 25, 2015 at 12:12 PM Drug News   - G J E 4
A new cholesterol-lowering drug called Praluent, made by Sanofi and Regeneron Pharmaceuticals has been approved by the US Food and Drug Administration. The agency approved the dug for people with certain genetic risk factors for heart disease.
US Regulatory Authorities Approve New Drug To Treat Patients With High Cholesterol
US Regulatory Authorities Approve New Drug To Treat Patients With High Cholesterol
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The injectable drug is the first of its kind to gain approval on the US market, and offers an alternative to popular pill-based statins.

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However, the US Food and Drug Administration approved it only for adults with an inherited condition that predisposes them to high cholesterol and raises the risk of heart attack and stroke.

"Praluent is approved for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH) or patients with clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol," the FDA said in a statement.

HeFH is an inherited condition that causes high levels of the bad kind of cholesterol, known as low-density lipoprotein (LDL) cholesterol.

Known also as alirocumab, the treatment is part of a new class of drugs known as proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors.

These drugs block the PCSK9 gene in the liver, which results in plummeting levels of LDL.

Source: AFP
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