EMA Makes Orphan Drug Recommendations - - BioPharm International

ADVERTISEMENT

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.

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

Compounding Pharmacy Issues Recall, But Challenges FDA Decision
July 22, 2014
AbbVie's Acquisition of Shire Could Save $8 Billion in Taxes
July 21, 2014
AbbVie to Acquire Shire for $54.7 Billion
July 18, 2014
AstraZeneca Reveals Design for New Global R&D Center and Corporate Headquarters
July 18, 2014
Particulate Matter Prompts Baxter's Recall of IV Solutions
July 17, 2014
Author Guidelines

Click here