www.fdanews.com/articles/82827-shire-files-idursulfase-with-emea-for-treatment-of-hunter-syndrome
SHIRE FILES IDURSULFASE WITH EMEA FOR TREATMENT OF HUNTER SYNDROME
December 2, 2005
Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for idursulfase for the treatment of Hunter syndrome. Review of a MAA by EMEA typically takes 12 months. If approved, this would be the first human enzyme replacement therapy for the treatment of Hunter syndrome, also known as Mucopolysaccharidosis II (MPS II).