Juxtapid (lomitapide) gains FDA approval

Prescription bottle - BSN

(Best Syndication News) - The U.S. Food and Drug Administration (FDA) approved Juxtapid (lomitapide) to treat a rare homozygous familial hypercholesterolemia (HoFH) disorder. Juxtapid should lower the low-density lipoprotein (LDL) cholesterol levels, the total cholesterol, apolipoprotein B, and non-high-density lipoprotein (non-HDL) cholesterol. The drug should be prescribed in conjunction with a low fat diet and other lipid reduction treatments.

In the United States, around one in one million people have HoFH. People with the rare condition do not effectively remove “bad” LDL cholesterol from their body. This puts HoFH individuals at an increased risk for heart attacks and death, often before the age of 30.

Juxtapid could aid HoFH individuals by interrupting the manufacture of lipid particles that lead to increased LDL levels in the blood. The medication will be in capsule form and should be taken once daily without food. They expect the medicine to be taken a minimum of two hours after the evening meal. Additionally, Juxtapid users should take fat-soluble vitamins and essential fatty acids daily to insure they are getting proper nutrition.

The FDA reviewed the results of a clinical trial of 29 HoFH patients taking Juxtapid. For those patients that could tolerate the medicine, the average reduction in LDL cholesterol levels was around one-half during the first 26 weeks.

The FDA has issued a Boxed Warning saying there is a serious risk for liver toxicity. The medicine could lead to fat being stored in the liver; this could cause progressive liver disease when the medicine is used continually. Another problem is that the drug could prevent fat-soluble nutrients from being absorbed. There are several medications that can interact with Juxatpid.

As part of the approval, the FDA will require Juxtapid to be investigated in three postmarketing studies. One study, involving animals, will investigate toxicity problems in children and teens. A second study will be a long-term study of registered HoFH patients that were treated with Juxtapid. The FDA wants to determine long-term safety.

The third study will involve a pharmacovigilance program intended to monitor reports of malignancy, teratogenicity, and hepatic abnormalities.

Adverse reactions that were commonly reported during the clinical trial were diarrhea, nausea, vomiting, indigestion, and abdominal pain.

Cambridge, Mass.-based Aegerion Pharmaceuticals, Inc. (NASDAQ:AEGR) is the marketer of Juxtapid.

By: Marsha Quinn

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