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What Country Has Just Approved Vertex Pharmaceuticals’ Orphan Drug Kalydeco (Ivacaftor) ?

December 3, 2012

       Health Canada on December 3, 2012, approves Vertex Pharmaceuticals’ orphan drug Kalydeco (Ivacaftor) for patients ages 6 and older with Cystic Fibrosis (CF), who have at least 1 copy of the G551D mutation in the CFTR gene. Approval is based on data from 2 global Phase III studies. It is estimated that 100 patients in Canada have the G551D mutation. 

        After Kalydeco receives approval from Health Canada, the drug “goes through the Common Drug Review (CDR) process, that conducts a cost-benefit analysis…. Each province and territory then conducts a review and makes its own reimbursement decision using the CDR recommendation as a guide”.       

References 

Cystic Fibrosis Canada December 3, 2012 Press Release  

Cystic Fibrosis Canada Kalydeco Page  

Blog Post titled “Cystic Fibrosis Canada Deadline of October 10, 2012, for Patient Input On Vertex Pharmaceuticals’ Orphan Drug Kalydeco”   

Blog Post titled, “Cystic Fibrosis Canada asks for Patient Input for Vertex Pharmaceuticals’ orphan drug Kalydeco”  

Copyright © 2012-2013, Orphan Druganaut Blog.  All rights reserved.

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