Japan approves Hunterase ICV for mucopolysaccharidosis type II (Hunter syndrome).- GC Pharma

GC Pharma and Clinigen has received Japan manufacturing and marketing approval for Hunterase ICV (intracerebroventricular) Injection 15 mg (idursulfase-beta (recombinant)) as a treatment for mucopolysaccharidosis type II (Hunter syndrome). In the result of the phase I/II study conducted by Dr. Torayuki Okuyama, principal investigator of the study, Department Head of Clinical Laboratory Medicine of the National Center for Child Health Development, Hunterase demonstrated a significant decrease of heparan sulfate in cerebrospinal fluid, which is regarded as the key factor for delayed cognitive development.