Hunter Syndrome :: ELAPRASE, idursulfase – therapy for Hunter syndrome patients in Europe
Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) today reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion recommending approval of ELAPRASE for the long-term treatment of patients with Hunter syndrome (Mucopolysaccharidosis II). The EU Marketing Authorisation is expected early in 2007 and will result in unified labelling that will be valid in the current EU 25 member states as well as in Iceland and Norway.