Aegerion Pharma files lomitapide for HoFH at EMA and FDA

Aegerion Pharmaceuticals a company focused on the development of novel therapeutics to treat severe lipid disorders, has announced that it has submitted a New Drug Application (NDA) to the FDA, and a Marketing Authorization Application (MAA) to the EMA seeking approval of its lead investigational therapeutic, lomitapide, as an adjunct to a low fat diet and other lipid-lowering therapies to reduce cholesterol in patients with Homozygous Familial Hypercholesterolemia (HoFH).Lomitapide holds orphan drug designation for the treatment of HoFH in the United States, and for the treatment of familial chylomicronemia (FC) in the U.S. and EU.