Juxtapid receives FDA approval for treatment of rare cholesterol disorder

Published on December 27, 2012 at 5:54 AM · No Comments

FDA approves new orphan drug for rare cholesterol disorder

On Dec. 21, the U.S. Food and Drug Administration approved Juxtapid (lomitapide) to reduce low-density lipoprotein (LDL) cholesterol, total cholesterol, apolipoprotein B, and non-high-density lipoprotein (non-HDL) cholesterol in patients with homozygous familial hypercholesterolemia (HoFH). Juxtapid is intended for use in combination with a low fat diet and other lipid-lowering treatments.

HoFH is a rare inherited condition that makes the body unable to remove LDL cholesterol, often called the "bad" cholesterol, from the blood, causing abnormally high levels of circulating LDL cholesterol. In the United States, HoFH occurs in approximately one in one million individuals. For those with HoFH, heart attacks and death often occur before age 30. Juxtapid works by impairing the creation of the lipid particles that ultimately give rise to LDL.

Juxtapid is a capsule taken once a day, without food, and at least two hours after the evening meal. Patients should take supplements that contain fat-soluble vitamins and essential fatty acids daily while taking Juxtapid.

"Juxtapid, in addition to diet changes and other cholesterol-lowering treatments, is a new option for those suffering with HoFH and the serious health consequences resulting from this condition," said Eric Colman, M.D., deputy director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research.

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