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news.US-based Aegerion Pharmaceuticals has secured a Notice of Compliance (NOC) from Health Canada for its JUXTAPID (lomitapide) capsules as an adjunct to a low-fat diet and other lipid-lowering drugs, with or without LDL apheresis, to reduce low-density lipoprotein cholesterol (LDL-C) in adult patients with homozygous familial hypercholesterolemia (HoFH), a serious and rare genetic disease.
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HoFH impairs the function of the receptor responsible for removing LDL-C (bad cholesterol) from the body and the loss of LDL receptor function results in extreme elevation of blood cholesterol levels.
Patients with HoFH often develop premature and progressive atherosclerosis, a narrowing or blocking of the arteries.
Aegerion CEO Marc Beer 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."
In Canada, based on the risk of liver toxicity, JUXTAPID capsules are subject to a risk management plan.
As the drug has a benefit-risk profile, its prescribing should be limited to physicians experienced in the diagnosis and treatment of familial hypercholesterolemia.
The safety and effectiveness of the drug have not been established in patients with hypercholesterolemia who do not have HoFH, or in pediatric patients, while the effect of JUXTAPID on cardiovascular morbidity and mortality has not been determined.