BRIEF: Aegerion receives FDA panel approval for lomitapide
Oct 18, 2012 (Menafn - Boston Herald - McClatchy-Tribune Information Services via COMTEX) --Cambridge-based Aegerion Pharmaceuticals Inc. said a U.S. Food and Drug Administration advisory panel has recommended approval of the company's drug candidate lomitapide, which would be used to treat patients suffering from the rare, life-threatening disease homozygous familial hypercholesterolemia.
The FDA has assigned a Prescription Drug User Free Act action date of Dec. 29 for completion of its review of the company's new drug application for lomitapide.
Lomitapide is a microsomal triglyceride transfer protein inhibitor Aegerion is developing as a once-a-day capsule for treating patients afflicted with certain severe lipid disorders, including HoFH.
The company said lomitapide has been evaluated in 14 Phase 1 and eight Phase II clinical trials, as well as a Phase III clinical trial in HoFH completed in 2011. Over 900 patients have been treated with the drug as part of these clinical trials.
An extension study to assess long-term safety is ongoing, Aegerion said. The company has also submitted a marketing authorization application to the European Medicines Agency requesting approval to market lomitapide.
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