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Internet Buzzes On FDA Advisory Committee Meeting (October 18, 2012) For Genzyme’s Orphan Drug Kynamro (Mipomersen)

October 18, 2012

       The October 18, 2012, FDA Advisory Committee recommends, in a 9-6 vote, Genzyme and Isis Pharmaceuticals’ orphan drug Kynamro (Mipomersen) for the treatment of Homozygous Familial Hypercholesterolemia (HoFH). The recommendation is reached despite concerns about side-effects, such as liver problems and a possible higher risk for cancer. FDA regulators will now have to decide by the end of January 2013, whether to grant final approval. 

        The Inter buzzes : 

1) October 18, 2012 article titled,”US FDA panel backs Sanofi, Isis drug for rare disorder” 

2)  Isis Pharmaceuticals October 18, 2012 Press Release titled,”FDA Advisory Committee Recommends Kynamro for Homozygous Familial Hypercholesterolemia”  

3) October 18, 2012 article titled,”FDA Panel Support Genzyme, Isis Drug Mipomersen on 9-6 Vote”  

4) October 18, 2012 article titled,”FDA Panel recommends approval of Mipomersen for Familial Hypercholesterolemia”  

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

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