EMA Makes Orphan Drug Recommendations - - BioPharm International

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EMA Makes Orphan Drug Recommendations



The European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) made recommendations for nine orphan drug designations during its June 2012 meeting. Included in COMP’s recommendations were four designation applications for rare forms of lipodystrophy.

The COMP meeting also confirmed Vertex Pharmaceuticals's Kalydeco (ivacaftor) for orphan designation. The confirmation follows the recommendation made by EMA’s Committee for Medicinal Products for Human Use (CHMP). Based on CHMP requirements, COMP confirmed that “Kalydeco continues to fulfill the orphan designation criteria.” COMP will publish the review of Kalydeco’s orphan designation after the European public assessment report for the drug is published.

COMP’s recommendations will be sent to the European Commission for adoption. Sponsors will have access to certain incentives during development once the orphan designation is granted.

A full list of COMP’s recommendations can be found in COMP’s monthly report.

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