Skip to content

Internet Buzzes About Posting Of FDA Advisory Committee Briefing Documents For Genzyme’s Orphan Drug Kynamro (Mipomersen)

October 17, 2012

       The FDA posted briefing materials for the October 18, 2012, Endocrinologic and Metabolic Advisory Committee meeting, to review Genzyme and Isis Pharmaceuticals’ orphan drug Kynamro (Mipomersen) for Homozygous Familial Hypercholesterolemia (HoFH). Mipromersen has a January 29, 2013, PDUFA date.  

       Internet Buzzes : 

1) October 16, 2012 article titled,”Isis Falls on Concerns Over Abnormal Growths With Kynamro”  

2) October 16, 2012 article titled,”FDA: Genzyme, Isis Drug Mipomersen Cuts Cholesterol but Impacts Liver”  

3) October 16, 2012 article titled,”FDA Review Raises Safety Concerns About Mipomersen”  

4) October 16, 2012 article titled,”Isis Pharma tumbles on Kynamro cancer concerns” 

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

Leave a Comment

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )


Connecting to %s

%d bloggers like this: