FDA Approves Lomitapide for HoFH
Following an October 2012 recommendation by the U.S. FDA's Endocrinologic and Metabolic Drugs Advisory Committee, the FDA has approved lomitapide for patients with homozygous FH. Lomitapide, known by the brand name Juxtapid, is produced by Aegerion Pharmaceuticals.
Results from the company's Phase III study evaluated the safety and effectiveness of the medicine at reducing LDL-C levels in adult patients with HoFH. The study was recently published in the online version of the Lancet. To further understand the drug's long-term safety and effectiveness, Aegerion has made a commitment to the FDA to conduct a post-approval, observational cohort study.