FDA Approves High-Priced Cholesterol Drug

A promising new cholesterol drug called Praluent (alirocumab) has been approved by the FDA, but it could become the new flashpoint in the growing battle over the high price of medications.

Praluent is part of a new line of drugs called PCSK9 inhibitors because they stifle a protein with that name that is involved in cholesterol regulation. The development of the drugs stemmed from the discovery that people with genetic mutations that lowered the activity of the protein have very low cholesterol and low cardiovascular risk.

The list price of Praluent is about $14,600 a year, which is substantially higher than the $7,000 to $12,000 that was expected by analysts. The pharmaceutical companies that created the drug—Sanofi and Regeneron Pharmaceuticals—said the price was justified by the potential benefits to patients and savings to the health care system that the drug would provide by preventing heart attacks and strokes.

In its decision on Friday, the FDA approved Praluent for patients who have had heart attacks, strokes, chest pain or related conditions, or have a genetic condition that causes high cholesterol and who require additional lowering of LDL despite taking the highest dose of a statin that they can tolerate. Studies aimed at determining if the drugs prevent heart attacks and strokes are underway, but results are not expected until about 2017.

Praluent would be self-injected every two weeks. The list price is $560 per injection for either dose, equivalent to $40 a day or $14,600 a year. Among the early users might be adults with so-called heterozygous familial hypercholesterolemia, an inherited condition that causes extremely high cholesterol and a substantially increased risk of heart attacks.

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