The Mexican Federal Commission for the Protection against Sanitary Risk (COFEPRIS) has approved Aegerion Pharmaceuticals’ Juxtapid (lomitapide) capsules for the treatment of homozygous familial hypercholesterolemia (HoFH).
Juxtapid capsules will be used as an adjunct treatment 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 (TC), apolipoprotein B (apo B) and non-high-density-lipoprotein cholesterol (non-HDL) in HoFH patients.
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HoFH is a serious, rare genetic disease that impairs the function of the receptor responsible for removing LDL-C from the body resulting in extreme elevation of blood cholesterol levels.
According to the company, HoFH patients frequently develop premature and progressive atherosclerosis, a narrowing or blocking of the arteries.
Aegerion chief executive officer Marc Beer said the company is happy to deliver Juxtapid as an adjunctive therapy to HoFH patients in Mexico.
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"With approval from COFEPRIS secured, we plan to build upon our established relationships with Mexican thought leaders in order to reach HoFH patients in need of treatment," Beer said.
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By GlobalDataThe company said that Juxtapid is subject to a risk management plan, which is approved by COFEPRIS, due to the risk of liver toxicity.
National Institute of Cardiology medical director and Mexican Society of Cardiologists president Juan Verdejo Paris said: "HoFH is a devastating disease and the approval of Juxtapid marks an important change in our ability to help reduce cholesterol in these patients."
In the Juxtapid clinical trial, ten of the 29 patients treated with the drug had at least one elevation in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than or equal to three times the upper limit of normal (ULN).
Image: Hypercholesterolemia is the presence of high levels of cholesterol in the blood. Photo: courtesy of freedigitalphotos.net.
