Aegerion Pharma's JUXTAPID Capsules Approved In Canada For HoFH Treatment

(RTTNews) - Aegerion Pharmaceuticals, Inc. (AEGR) said that Health Canada has granted a Notice of Compliance or NOC, approving JUXTAPID as an adjunct to a low-fat diet and other lipid-lowering drugs, with or without LDL apheresis, to reduce low-density lipoprotein cholesterol or LDL-C in adult patients with homozygous familial hypercholesterolemia or HoFH.

HoFH is a serious, rare genetic disease that impairs the function of the receptor responsible for removing LDL-C or "bad" cholesterol from the body. A loss of LDL receptor function results in extreme elevation of blood cholesterol levels. Often, HoFH patients develop premature and progressive atherosclerosis, a narrowing or blocking of the arteries.

Aegerion's Chief Executive said: "We expect Canada to be an important market for Aegerion, and with infrastructure established, we look forward to providing JUXTAPID to HoFH patients in need of therapy."

Based on the risk of liver toxicity, JUXTAPID is subject to a risk management plan in Canada. Owing to its benefit-risk profile, the prescribing of JUXTAPID should be limited to physicians experienced in the diagnosis and treatment of familial hypercholesterolemia. The safety and effectiveness of JUXTAPID have not been established in patients with hypercholesterolemia who do not have HoFH, or in pediatric patients. The JUXTAPID effect on cardiovascular morbidity and mortality has not been determined.