CAMBRIDGE, Mass., Dec. 24, 2012 (GLOBE NEWSWIRE) -- Aegerion Pharmaceuticals, Inc. (Nasdaq:AEGR), a biopharmaceutical company dedicated to the development and commercialization of novel, life-altering therapies for patients with debilitating, often fatal, rare diseases, today announced that the U.S. Food & Drug Administration (FDA) has approved JUXTAPID™ (lomitapide) capsules as an adjunct 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).
"We are excited that JUXTAPID will become a new treatment option for patients with HoFH," said Marc Beer, Chief Executive Officer at Aegerion. "The approval of our first product also marks an important corporate milestone for Aegerion and reflects our commitment to help patients in need."
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."The FDA approval of JUXTAPID is a major step forward for HoFH patients and their families, who have long been waiting for new therapies," said Katherine Wilemon, president and founder of The FH Foundation. "New treatments, combined with further understanding and awareness of this disease, can bring much needed hope to the HoFH community." JUXTAPID contains a Boxed Warning citing the risk of hepatic toxicity. See below for Important Safety Information about JUXTAPID, including the Boxed Warning, Contraindications and Warnings and Precautions. 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.
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