ElapraseTreatment for Mucopolysaccharidosis Type II
Update: Elaprase Now FDA Approved - July 24, 2006
Shire Provides Update on U.S. Marketing Application of Elaprase
CAMBRIDGE, Massachusetts and BASINGSTOKE, England, May 17, 2006 -- Shire plc announces that the Food and Drug Administration (FDA) has extended by 90 days the review period for the biologics license application (BLA) for Elaprase (idursulfase). This extension will allow the FDA additional time to review data and analyses they recently requested during label discussions. Therefore, the FDA advised us at close of US business yesterday that the new action date for the application is August 24, 2006.
"Shire will continue to work closely with the FDA during this brief extension of the Elaprase BLA review and through this cooperative effort we expect that Elaprase will be approved and launched by the third quarter 2006," said Matthew Emmens, Chief Executive Officer of Shire. "There is no existing treatment for patients with Hunter syndrome and Shire is confident that the FDA recognizes the importance of making Elaprase available to these patients."
The US BLA for Elaprase was submitted in November 2005 and was granted priority review, requiring the FDA to take action within six months. A marketing authorization application for Elaprase has been submitted to the European Medicines Agency, and Shire expects a response on that application before the end of the year.
Elaprase has been developed for the treatment of Hunter syndrome, a serious genetic disorder, mainly affecting males, that interferes with the body's ability to break down and recycle specific chemicals called mucopolysaccharides, also known as glycosaminoglycans or GAG. Hunter syndrome is one of several related lysosomal storage diseases.
About Hunter Syndrome
Hunter syndrome (MPS II) is a serious genetic disorder mainly affecting males that interferes with the body's ability to break down and recycle specific chemicals called mucopolysaccharides, also known as glycosaminoglycans or GAG. Hunter syndrome is one of several related lysosomal storage diseases.
Shire estimates there are approximately 2,000 patients worldwide afflicted with Hunter syndrome in countries where reimbursement may be possible.
More information about Hunter syndrome can be found at www.hunterpatients.com.
Source: Shire plc
Posted: May 2006
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