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Oct21
ELAPRASE™ (idulsulfase) Received Positive Opinion From European Regulatory Agency
ELAPRASE™ (idulsulfase) by Shire plc (LON: SHP, Nasdaq: SHPGY) has been given a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA), thereby recommending the approval of ELAPRASE for the long-term treatment of patients with Hunter syndrome (Mucopolysaccharidosis II).

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.

Without this enzyme, cellular waste products accumulate in tissues and organs, which then begin to malfunction.

Life expectancy for people with the severe form of the disease is commonly 10 to 20 years.

Expected early in 2007, the EU Marketing Authorisation will result in a unified labelling that will be valid in the current EU 25 member states as well as in Iceland and Norway.

Earlier this year, ELAPRASE has been approved by the USFDA for Hunter syndrome.

Source: Shire plc

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« Tm Bioscience Amended License Agreement with Sirius Genomics | Main | PharmaNova Granted Exclusive U.S. License to Depomed for the Use of Extended Release Gabapentin against Hot Flashes »

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