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New medication shows promise as lipid-lowering therapy for rare cholesterol disorder
Date:11/2/2012

nd on a study in a rabbit model of the disease, Rader felt it would be effective against HoFH.

A proof of principle study conducted by Drs. Cuchel and Rader at Penn in six HoFH patients confirmed that lomitapide was highly effective in reducing LDL and provided the basis for the international phase 3 study, which was funded in part by the Office of Orphan Product Development at the Food and Drug Administration (FDA). Aegerion Pharmaceuticals in-licensed lomitapide from Penn in 2006, helping fund the completion of the study and the additional work required to submit a new drug application to the FDA.

On October 17, 2012, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee recommended by a vote of 13 to 2 the approval of lomitapide to reduce LDL in patients with HoFH. The FDA is scheduled to make a final decision on approval of the medication by the end of year.

"The more than 15-year story of this therapy is the result of an enormous collaboration between academia, foundation, pharmaceutical and biotech industries, and the government," said Rader. "If lomitapide is approved and is made available to patients with this fatal disease, it will serve as a model for how different sectors can work together to bring new medicines to patients with large unmet medical need."


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Contact: Jessica Mikulski
jessica.mikulski@uphs.upenn.edu
215-349-8369
University of Pennsylvania School of Medicine
Source:Eurekalert

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