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Internet Buzzing About FDA Advisory Committee Recommendation For Approval Of Aegerion Pharmaceuticals’ Orphan Drug Lomitapide

October 17, 2012

       On October 17, 2012, Aegerion Pharmaceuticals announces that the FDA Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) by a vote of 13 to 2, that orphan drug Lomitapide is presented with sufficient safety and efficacy data to support its marketing. Lomitapide is for the treatment of Homozygous Familial Hypercholesterolemia (HoFH) when used as an adjunct to a low-fat diet and other lipid-lowering therapies. The FDA does not have to follow the recommendation.  Lomitapide has a December 29, 2012, PDUFA date

        The Internet is Buzzing : 

1)  Bloomberg October 17, 2012 article titled,”Aegerion Drug Wins Panel Support for Cholesterol Disease”  

2) October 17, 2012 article titled,”FDA Reviewers Recommend Approval for Lomitapide for Homozygous Familial Hypercholesterolemia”  

3) October 17, 2012 article titled,”Aegerion Pharma FDA Panel Live Blog”  

Copyright  © 2012-2013, Ann-Teresa Cusenza and Orphan Druganaut Blog.  All rights reserved.

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