FDA APPROVES NEW CHOLESTEROL-LOWERING DRUG

By admin
November 08, 2015

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ATLANTA (CNN) – The FDA recently approved the new generation of cholesterol lowering drug called alirocumab, brand name Praluent. The injectable drug, from Regeneron and Sanofi, is the first in a new class of medications called PCSK9 inhibitors, which work by making the liver more efficient at getting rid of LDL, or bad cholesterol.

Praluent is approved for patients with heterozygous familial hypercholesterolemia, or HeFh, which is an inherited condition that causes high LDL cholesterol levels. It is also approved for patients who have had a heart attack or stroke. This offers another treatment option for patients who aren’t responding to other medications such as statins, or who can’t take them because they experience side effects. With more research, the new drug could be approved more broadly for patients at high risk who have not had a heart attack or stroke.

Praluent is available in two doses as a prefilled injection pen that patients administer to themselves once every two weeks. The wholesale cost of the drug will be about $1,200 per month. The cost for patients will depend on their insurance plan. By comparison, statins cost between $500 and $700 a year for name-brand versions and $48 a year for generics. As with most medications, the drug has some potential side effects.

The new drug is a “powerful new way of lowering the bad form of cholesterol, and that has profound implications in dealing with the burden of vascular disease,” said Dr. Elliott Antman, president of the American Heart Association.

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