FDA approves new cholesterol lowering drug, but how much will it cost?

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A Food and Drug Administration advisory committee on Tuesday recommended approval of a new type of experimental cholesterol-fighting drug that could be more potent and carry fewer side effects than statins, which are among the most prescribed drugs in the United States.

ATLANTA — The FDA approved the new cholesterol lowering drug alirocumab, brand name Praluent, on Friday. The injectable drug, from Regenron and Sanofi, is the first in a new class of drugs called PCSK9 inhibitors.

“The drug works by reducing the number of receptors on the liver that remove LDL cholesterol from the blood. By blocking PCSK9’s ability to work, more receptors are available to get rid of LDL cholesterol from the blood and, as a result, lower LDL cholesterol levels,” said the FDA.

This offers another treatment option for patients, who aren’t responding to currently available medications or who can’t take them because they experience side effects.

The currently available medications for lowering cholesterol are statins, of which there are seven on the market.

Regenron said Friday the drug will be available as soon as early next week in two doses. The wholesale cost of the drug will be $40 per day which comes out to be about $1200 per month. The cost for patients will depend on their individual insurance plan. In comparison, statins cost between $500 and $700 a year for name-brand versions and $48 a year for generics.

An FDA advisory committee recommended the drug for approval in June. Today was the deadline for the agency to make a decision on whether or not to approve the drug.

In June the same advisory committee also recommended another new drug, evolocumab, brand name Repatha, which is still being considered by the FDA and was approved in Europe earlier this week.

The new drugs are a “powerful new way of lowering the bad form of cholesterol, and that has profound implications in dealing with the burden of vascular disease,” which can lead to heart attacks and stroke, Dr. Elliott Antman, president of the American Heart Association, told CNN in June.

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