Hunter Syndrome

Elaprase (idursulfase) receives positive opinion in Europe

Published in Lab Law Weekly, November 24th, 2006

Shire plc (SHP; SHPGY; SHQ) 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 E.U. Marketing Authorisation is expected early in 2007 and will result in unified labelling that will be valid in the current E.U. 25-member states as well as in Iceland and Norway.

Hunter syndrome is a very rare, life-threatening genetic condition that affects mostly males and results from the absence or deficiency of the lysosomal enzyme iduronate-2-sulfatase....

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Source: Lab Law Weekly (2006-11-24)

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