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.
For more information call (855) 898-2743 or visit www.juxtapid.com.