CAMBRIDGE, Mass., Aug. 1, 2013 (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, announced today that the European Commission has approved LOJUXTA™ (lomitapide) hard capsules as an adjunct to a low-fat diet and other lipid-lowering medicinal products with or without low density lipoprotein (LDL) apheresis in adult patients with homozygous familial hypercholesterolemia (HoFH).
"The approval of LOJUXTA marks an important day for patients in Europe with HoFH, and is a major step for Aegerion in our goal to bring therapy to patients globally," said Marc D. Beer, Chief Executive Officer of Aegerion. "We are now keenly focused on launch, and are actively working with national health authorities in an effort to make LOJUXTA available as swiftly as possible."
"HoFH is a rare and serious medical condition," said Prof. Alberico L. Catapano, President of the European Atherosclerosis Society. "Despite the treatments we have available today, patients continue to experience severe elevations in LDL-C. With novel therapies such as LOJUXTA it is possible to achieve target levels in LDL-C for patients with HoFH. This marks a change in our ability in daily practice to truly impact the lives of these patients."LOJUXTA is indicated as an adjunct to a low-fat diet and other lipid-lowering medicinal products with or without low density lipoprotein (LDL) apheresis in adult patients with homozygous familial hypercholesterolemia (HoFH). The Summary of Product Characteristics (SPC) describes that genetic confirmation of HoFH should be obtained whenever possible, and that other forms of primary hyperlipoproteinemia and secondary causes of hypercholesterolemia (e.g., nephrotic syndrome, hypothyroidism) must be excluded. The European Commission's decision is based on a favorable benefit-risk assessment from Aegerion's Phase 3 study which evaluated the safety and efficacy of the medicine to reduce LDL-C levels in 29 adult patients with HoFH.