Aegerion Pharmaceuticals, Inc. Announces FDA Acceptance of New Drug Application for Review
Published: Apr 30, 2012
CAMBRIDGE, Mass., April 30, 2012 (GLOBE NEWSWIRE) -- Aegerion Pharmaceuticals, Inc. (Nasdaq:AEGR), an emerging biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat debilitating and often fatal rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for lomitapide, a once-daily, oral treatment for Homozygous Familial Hypercholesterolemia (HoFH), for review. Aegerion is seeking authorization to market lomitapide as an adjunct to a low-fat diet and other lipid-lowering therapies to reduce cholesterol in patients with HoFH. As previously disclosed, the FDA has classified the submission as a standard review with a 10-month Prescription Drug User Fee Act (PDUFA) timetable.