Aegerion gains European approval for rare disease drug

5 August 2013

The European Commission has approved US biopharma company Aegerion Pharmaceuticals’ (Nasdaq: AEGR) 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), a rare and serious medical condition.

"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 Beer, chief executive of Aegerion, adding: "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."

Alberico Catapano, president of the European Atherosclerosis Society quoted by Aegerion, commented: "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."

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