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Shire's Replagal is fast-tracked by the FDA

Shire has received Fast Track designation from the FDA for its enzyme replacement therapy for Fabry disease, Replagal (agalsidase alfa)

Speciality biopharmaceutical company, Shire has received Fast Track designation from the FDA for its enzyme replacement therapy for Fabry disease, Replagal (agalsidase alfa).

Shire requested Fast Track designation at the suggestion of the FDA after the regulator requested additional data to back-up Shire's Biologics License Application (BLA), which the pharma company then withdrew.

Following its receipt of Fast Track approval, Shire will initiate the rolling submission of the Replagal BLA, and will submit the requested additional data later this year.

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

Replagal is currently approved for the treatment of Fabry disease in 45 countries worldwide. The drug was made available to US patients in December 2009 through the Replagal early access programme, an FDA-approved treatment protocol, put in place as a result of the supply disruption of the only currently marketed treatment for Fabry disease in the US.

Fabry disease is estimated to affect between 8,000 and 10,000 people worldwide. The condition affects both men and women and can reduce lifespan by around 20 years in men and 15 years in women. Principal causes of death are renal failure, cardiomyopathy and cerebrovascular events such as stroke.

25th February 2010

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