Shire plc (SHP.L,SHPGY) announced that it has submitted a Biologics License Application with the FDA for REPLAGAL, its enzyme replacement therapy for Fabry disease.
REPLAGAL is currently available to U.S. Fabry patients under an FDA-approved treatment protocol, and the company is also supporting emergency IND requests.
The company also provided an update on recent key activities regarding global access to velaglucerase alfa, its enzyme replacement therapy in development for Type 1 Gaucher disease. The company said it has submitted marketing applications for velaglucerase alfa in the U.S., EU and Canada. In the U.S., the application is being reviewed by the FDA under Priority Review with a PDUFA date of February 28, 2010. The CHMP has granted accelerated review for the EU MAA.
The company said FDA recently completed the pre-approval inspections of Shire's Cambridge and Lexington Massachusetts facilities for the manufacturing and testing of velaglucerase alfa.
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