Aegerion Pharmaceuticals announced that the FDA has approved Juxtapid (lomitapide capsules) as an adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol,  apolipoprotein B and non- high-density-lipoprotein cholesterol in patients with homozygous familial hypercholesterolemia (HoFH). Lomitapide is a MTP-inhibitor that reduces blood levels of cholesterol and triglyceride by limiting the production of lipoproteins from the intestine and liver.

The approval of Juxtapid was based on a multinational, single-arm, open-label, 78-week Phase 3 study, which evaluated the safety and effectiveness of the medicine to reduce LDL-C levels in 29 adult patients with HoFH. When added to the patients’ existing lipid-lowering therapy, Juxtapid significantly reduced LDL-C by 40% at Week 26 in the intent-to-treat population with last observation carried forward for the patients who discontinued prematurely. LDL-C was reduced by an average of 50% for the 23 patients who completed the study through Week 26.

Because of the risk of liver toxicity, Juxtapid is available only through a restricted program called the Juxtapid Risk Evaluation and Mitigation Strategy (REMS) Program. Aegerion will certify all health care providers who prescribe Juxtapid and the pharmacies that will dispense the medicine.

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