Aegerion Pharmaceuticals, Inc., a biopharmaceutical company, has received the Mexican Federal Commission for the Protection against Sanitary Risk (COFEPRIS) approval for its Juxtapid 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 patients with homozygous familial hypercholesterolemia (HoFH).

In the approval of Juxtapid, COFEPRIS gave Juxtapid Recognition as an Orphan Drug.

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

"We are pleased to be able to deliver Juxtapid as an adjunctive therapy to HoFH patients in Mexico," said Marc Beer, chief executive officer of Aegerion. "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."

"HoFH is a devastating disease, and the approval of Juxtapid marks an important change in our ability to help reduce cholesterol in these patients," said Dr Juan Verdejo Paris, medical director at the National Institute of Cardiology and president of the Mexican Society of Cardiologists. "I hope that with this newly available therapy, we can also raise awareness and understanding of the disease."

Due to the risk of liver toxicity, Juxtapid is subject to a risk management plan that has been approved by COFEPRIS.

The safety and effectiveness of Juxtapid have not been established in patients with hypercholesterolemia who do not have HoFH. The effect of Juxtapid on cardiovascular morbidity and mortality has not been determined. The safety and effectiveness of Juxtapid have not been established in pediatric patients.

Aegerion Pharmaceuticals is dedicated to the development and commercialization of innovative therapies for patients with debilitating rare diseases.