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November 04, 2009
FDA grants priority review to Shire's velaglucerase alfa for Gaucher disease
by Mark Todoruk

Shire announced Wednesday that the FDA granted priority review to velaglucerase alfa for the treatment of Type 1 Gaucher disease, and that a decision on the drug's approval is expected by February 28, 2010.

Velaglucerase alfa is already available to patients with Gaucher disease under a treatment protocol that was accepted by the FDA. The access programme is intended to address a shortage of Genzyme's Cerezyme (imiglucerase).

Reference Articles

 FDA will fast-track review of Shire’s Gaucher disease treatment - (Boston Herald)
 Shire: FDA grants priority review for Shire's velaglucerase - (Morningstar)
 FDA grants priority review for Shire’s velaglucerase alfa for type 1 Gaucher disease - (Shire)
 Shire Gaucher drug gets FDA priority review - (The Boston Globe)



 
FirstWord PLUS Products mentioned in this article:
Cerezyme | velaglucerase alfa

FirstWord PLUS Companies mentioned in this article:
Genzyme | Shire
 

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