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Shire Provides Update on Biologics License Application (BLA) Filing for REPLAGAL(R) (agalsidase alfa) With the U.S. Food and Drug Administration (FDA)
Date:2/24/2010

As a result of this request, Shire withdrew its December BLA filing, and, at the suggestion of the FDA, requested and received Fast Track designation. Shire will immediately initiate the rolling submission of the REPLAGAL BLA, and will submit the requested pharmacokinetic data around mid-year.

Fast Track designation is an FDA-approved process that facilitates the development and expedites the review of drugs to treat serious diseases and fill an unmet medical need with the goal of getting important new treatments to patients earlier. This process allows a company to file the sections of the BLA as they become available instead of filing all the sections at once. It also enables the agency to commence its review and proceed on a rolling basis as the additional sections are completed and submitted for review.

"We will continue to work closely with the FDA in the coming months on the rolling BLA submission for REPLAGAL, "said Sylvie Gregoire, President, Shire Human Genetic Therapies. "We remain committed to continuing to provide Fabry patients in the United States with REPLAGAL under the treatment protocol."

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