Shire: EU Elaprase approval to be completed by year end
25 July 2006 00:00 in Pharmaceutical Company Product News
Shire, the UK's third largest pharmaceutical company, has said it expects the European Medicines Agency (EMEA) to have completed its marketing authorisation review for Elaprase by the end of the year.
Elaprase is a human enzyme replacement therapy for the treatment of Hunter syndrome, a rare disease characterised by the body's failure to produce iduronate-2-sulfatase, an enzyme responsible for the removal of some types of cellular waste products.
Without this enzyme, these waste products can build up, causing tissue scarring of the skin and organs, as well as malfunction. Elaprase is a synthetic version of the enzyme that was yesterday approved by the FDA, which could provide an indication that the EMEA will follow suit.
Matthew Emmens, Shire's chief executive, stated: "The FDA approval of Elaprase marks a significant milestone in Shire's effort to provide meaningful treatments for patients suffering from genetic diseases."
"A hallmark of the Elaprase program is the commitment demonstrated by patients and families, investigators and Shire employees involved in the development effort," he added.
Dr Joseph Muenzer of the University of North Carolina at Chapel Hill concluded: "Regulatory approval of Elaprase will enable physicians to move needy patients beyond palliative care and make Hunter syndrome a treatable disease."
According to Patient Plus, an online health information service, Hunter syndrome afflicts one in 140,000 live births, from a survey in Northern Ireland. There are two types of the disease: a severe form (type A) and a mild form (type B). © Adfero Ltd
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