Health Canada has granted a notice of compliance (NOC) approving Aegerion Pharmaceuticals’ JUXTAPID, for treating a serious and rare genetic disease homozygous familial hypercholesterolemia (HoFH).
JUXTAPID is indicated 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 HoFH patients.
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HoFH impairs the function of the receptor that is 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.
Aegerion CEO Marc Beer said: “Approval in Canada marks another key milestone in our plan for global expansion.”
Based on the risk of liver toxicity, JUXTAPID capsules are subject to a risk management plan, the JUXTAPID REMS programme in Canada.
Due to the drug’s benefit-risk profile, its prescribing should be limited to physicians experienced in the diagnosis and treatment of familial hypercholesterolemia, the company said.
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By GlobalDataSafety and effectiveness of the drug have not been established in patients with hypercholesterolemia who do not have HoFH, or in paediatric patients and the effect of JUXTAPID on cardiovascular morbidity and mortality has also not been determined.
In the JUXTAPID clinical study, ten of the 29 patients treated with the drug had at least one elevation in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3x upper limit of normal (ULN) and there were no concomitant clinically meaningful elevations of total bilirubin, international normalised ratio (INR), or alkaline phosphatase.
The drug also increases hepatic fat, with or without concomitant increases in transaminases and the median absolute increase in hepatic fat was 6% after both 26 and 78 weeks of treatment, from 1% at baseline, measured by magnetic resonance spectroscopy.
Patients with HoFH often develop premature and progressive atherosclerosis, a narrowing or blocking of the arteries.
Image: Spacefill model of the Cholesterol molecule. Photo: courtesy of RedAndr.
