Shire plc (SHPGY,SHP.L) announced that the United States Food and Drug Administration or FDA has granted Priority Review for the New Drug Application or NDA for velaglucerase alfa, the company's enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease.
The FDA has issued an action date for the NDA of February 28, 2010 under the Prescription Drug User Fee Act. In the U.S., patients continue to be enrolled in an FDA-approved treatment protocol, under which Gaucher patients receive velaglucerase alfa prior to commercialization, the company added. In addition, Shire confirmed that it is on track with its filing of the Marketing Authorization Application (MAA) in the EU for 2009.
Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists, and accelerates the target review timing from ten to six months. Gaucher disease is an autosomal recessive disorder caused by mutations in the GBA gene, resulting in a deficiency of the lysosomal enzyme beta-glucocerebrosidase.
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