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Internet Buzzes About Posting of FDA Advisory Committee Briefing Documents For Aegerion Pharmaceuticals’ Orphan Drug Lomitapide

October 15, 2012

       The FDA has posted briefing materials for the October 17, 2012 Endocrinologic and Metabolic Advisory Committee meeting, to review Aegerion Pharmaceuticals’ orphan drug Lomitapide for Homozygous Familial Hypercholesterolemia (HoFH).    

         Per an October 15, 2012 article : 

  1. FDA posted documents support the clinical efficacy argument that Aegerion Pharmaceuticals presented from its small Phase III pivotal study
  2. FDA posted documents shows FDA “fretting over Lomitapide potential impact on the liver – a red flag in safety reviews”
  3. The “lengthy, dispassionate” FDA Review Document  identifies the adverse events & also says that the right kind of REMS “could effectively guard against risk factors”. 

      Other Internet Buzz : 

1) October 15, 2012 article titled,”Aegerion Shares Rise on Report of High Cholesterol Drug”  

2) October 15, 2012 article titled,”FDA: Aegerion Drug Cuts Cholesterol But Has Liver Safety Risk”     

3) October 15, 2012 article titled,”FDA Reviewers Raise No New Red Flags Over Lomitapide” 

4) October 15, 2012 article titled,”Aegerion Lomitapide Briefing Docs Posted; FDA Panel Says More Patients Needed To Rule Out Cancer Risk”  

5) October 15, 2012 article titled,”FDA: Aegerion drug effective, but carries risks”. 

       Per’s “Social Media Monitoring page for Aegerion” : 

# of Twitter tweets in the last 24 hours = 82

Average Twitter tweets per 24 hours = 10.     

       On Thursday, October 18, 2012, the same committee will meet to discuss the same indication for Genzyme’s Mipomersen. 

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

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