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Synageva lands orphan drug status in Europe

Tue, 11/09/2010 - 9:36am
Mass High Tech: The Journal of New England Technology

Synageva BioPharma Corp. has won orphan drug status from the European Medicines Agency (EMA) for its enzyme replacement therapy, SBC-102, to treat Lysosomal Acid Lipase Deficiency.

The EMA grants orphan status to potential treatments of rare diseases, affecting fewer than five in 10,000 people in the European Union. Under such designation, the Lexington-based biotech may have access to centralized marketing authorization with 10-year marketing exclusivity post-approval, protocol assistance and fee reductions or exemptions.

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