Aegerion Pharmaceuticals Comments on Standard Review Classification for Lomitapide NDA

Aegerion Pharmaceuticals, Inc.

, an emerging biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat severe lipid disorders, today commented on U.S. Food and Drug Administration (FDA)'s standard review classification of Aegerion's New Drug Application for its lead investigational therapeutic, lomitapide. Lomitapide is a small molecule, microsomal triglyceride transfer protein inhibitor, or MTP-I, in development as a once-daily oral therapeutic for use as an adjunct to a low-fat diet and other lipid-lowering therapies to reduce cholesterol in patients with Homozygous Familial Hypercholesterolemia (HoFH). HoFH is a rare genetic lipid disorder resulting in an accumulation of low-density lipoprotein (LDL-C) cholesterol in the blood. Patients diagnosed with HoFH typically have as much as three to six times the normal amount of LDL-C while on a variety of lipid-lowering drug treatments, putting them at risk for a major cardiovascular event.