Trials & Filings

COMP Gives Positive Opinion for Gentium’s Defibrotide

Orphan drug to treat GvHD

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

The EMA’s Committee for Orphan Medicinal Products (COMP) has issued a positive opinion on Gentium‘s application for orphan medicinal product status for Defibrotide for the prevention of Graft versus Host Disease (GvHD). The positive opinion of the COMP has now been forwarded to the EU commission for final approval and publication in the EU community register. Orphan drug status is granted to products that can be used in the diagnosis, treatment or prevention of life-threatening dise...

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