Aegerion Pharmaceuticals Inc. (AEGR) announced that the Endocrinologic and Metabolic Drugs Advisory Committee or EMDAC of the U.S. Food and Drug Administration or FDA determined by a vote of 13 to 2 that Aegerion has presented sufficient safety and efficacy data to support marketing of its product, lomitapide, for the treatment of patients with Homozygous Familial Hypercholesterolemia or HoFH when used as an adjunct to a low-fat diet and other lipid-lowering therapies.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of December 29, 2012, for completion of its review of the New Drug Application or NDA for lomitapide.
The EMDAC provides the FDA with independent expert advice and recommendations. The FDA is not bound by the EMDAC's recommendation, but will consider the committee's recommendation as the FDA completes its review of the lomitapide NDA.
For comments and feedback: editorial@rttnews.com