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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 diseases with an incidence of no more than 5 in 10.000 in the European Union. In order to receive Orphan status, there must also be either no satisfactory method of diagnosis, prevention or treatment of the authorized condition, or if such a method exists, the medicine must potentially be of a significant benefit to those affected by the condition. Orphan status confers 10 years of marketing exclusivity in all EU member countries following approval and in addition a range of other benefits during the development and regulatory review process including scientific assistance for study protocols, access to the centralized review process covering all member countries and a reduction or elimination of registration and marketing authorization fees.

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