YONGIN, South Korea--(BUSINESS WIRE)--GC Pharma (006280.KS) today announced that the European Medicines Agency (EMA) granted orphan drug designation (ODD) to Hunterase ICV (intracerebroventricular, generic name: idursulfase-beta (recombinant)) for the treatment of mucopolysaccharidosis type II (Hunter syndrome) in the European Union.
Clinigen K.K. and GC Pharma have recently announced an exclusive licensing agreement in Japan to commercialize Hunterase (Idursulfase-beta) ICV, a human recombinant iduronate-2-sulfatase (IDS) used in enzyme replacement therapy for the treatment of Hunter syndrome. Used as one of the methods for Hunter syndrome treatment, intravenous injection does not penetrate the blood brain barrier in clinically adequate amounts.
Shire's Biological Idursulfase Receives Supplemental Approval in US
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