Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that the United States Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for velaglucerase alfa, the company's enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease.
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. The FDA has issued an action date for the NDA of February 28, 2010 under the Prescription Drug User Fee Act (PDUFA).
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. Shire has also engaged with national and regional authorities outside the U.S. and patients are receiving velaglucerase alfa through pre-approval access programs. Shire confirms it is on track with its filing of the Marketing Authorization Application (MAA) in the EU for 2009.