Idursulfase Approved in Brazil for Treatment of Hunter Syndrome
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Idursulfase Approved in Brazil for Treatment of Hunter Syndrome

CAMBRIDGE, Mass -- May 27, 2008 -- The Brazilian Regulatory Agency, Agência Nacional de Vigilância Sanitária, has approved idursulfase (ELAPRASE), a human enzyme-replacement therapy for the treatment of Hunter syndrome. Idursulfase is developed by Shire Human Genetic Therapies, a business unit of Shire focused on genetic diseases, and is the first and only enzyme-replacement therapy approved for people suffering from Hunter syndrome. With this approval, idursulfase is now cleared for marketing in 2 countries in the region: Brazil and Mexico. Idursulfase was approved in the United States in July 2006 and is approved for use in 40 countries.

Idursulfase, which is given as a weekly infusion, is designed to replace the deficient iduronate-2-sulfatase enzyme demonstrated in patients with Hunter syndrome.

"This is a tremendous milestone for the many Hunter syndrome patients in Brazil, who will now have access to treatment for this serious and life-threatening disease," said Professor Roberto Giugliani, MD, PhD, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil. "With [idursulfase], physicians will now be able to move patients beyond palliative care and provide specific treatment for Hunter syndrome."

SOURCE: Shire Limited

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