Aegerion Pharmaceuticals Announces Date of FDA Advisory Committee Review of Lomitapide NDA
CAMBRIDGE, Mass., Aug. 14, 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 scheduled a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee on October 17, 2012, to review the Company's New Drug Application for lomitapide in the treatment of adult patients with Homozygous Familial Hypercholesterolemia (HoFH). Details of the meeting will be available in the Federal Register.
The Endocrinologic and Metabolic Drugs Advisory Committee is an independent panel of experts that reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of endocrine and metabolic disorders, and makes appropriate recommendations to the FDA. Aegerion is seeking authorization to market lomitapide as an adjunct to a low-fat diet and other lipid-lowering therapies to reduce cholesterol in adult patients with HoFH.
Lomitapide is a small molecule microsomal triglyceride transfer protein inhibitor (MTP-I) that Aegerion is developing as a once-a-day oral therapeutic for the treatment of patients with certain severe lipid disorders, including HoFH and familial chylomicronemia (FC). MTP exists in both the liver and intestines where it plays a role in the formation of lipoproteins containing cholesterol and triglycerides. Currently, there is no MTP-I approved by the FDA for any indication.
HoFH is a rare genetic lipid disorder usually caused by defects in the low-density lipoprotein, or LDL, receptor genes, resulting in impaired or total loss of function in the LDL receptor. The LDL receptor is a protein on the surface of cells that is responsible for binding to and removing LDL from the blood. A loss of LDL receptor function results in accumulation of LDL-C in the blood.
Untreated HoFH patients have extremely high LDL-C levels, typically between 400 mg/dL and 1,000 mg/dL. These patients are at severely high risk of experiencing premature cardiovascular events, such as heart attack or stroke, often experiencing their first cardiovascular event in their twenties. If untreated, patients with HoFH generally die before the age of thirty.
About Aegerion Pharmaceuticals, Inc.
Aegerion Pharmaceuticals, Inc. is an emerging biopharmaceutical company focused on the development and commercialization of novel, life-altering therapeutics to treat debilitating and often fatal rare diseases. Aegerion is motivated by its commitment to patients first. We are also attentive to our core values of integrity, innovation, responsibility to healthcare providers, development of employees and always scientific and clinical excellence.
CONTACT: Aegerion Pharmaceuticals, Inc. Michael Lawless, VP, IR (857) 242-5028 LaVoie Group Amanda Murphy (978) 745-4200 X103Source: Aegerion Pharmaceuticals, Inc. 2012 GlobeNewswire, Inc.