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Print Edition StoriesThursday, November 5, 2009
Shire's Gaucher drug gets FDA priority review
By Mass High Tech staff
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The U.S. Food and Drug Administration has granted priority review for Shire PLC’s previously announced new drug application for its treatment of Gaucher disease. If approved, the drug candidate would serve as an alternative to Genzyme’s Cerezyme drug, which has faced shortages due to Genzyme’s earlier manufacturing plant shutdown in Allston.
Shire’s treatment, velaglucerase alfa, is intended as an enzyme replacement therapy for Type 1 Gaucher disease, a rare genetic disorder that can result in bone pain and severe anemia.
Shire (Nasdaq: SHPGY), whose Human Genetic Therapies division is headquartered in Lexington, announced early in September that it had sent the new drug application to the FDA. The accelerated timing for the drug review reduces the time frame for approval from ten to six months. Shire’s drug candidate is expected to receive notice from the FDA by Feb. 28, 2010.
The company said in a press release that some Gaucher patients outside the U.S. are being treated with Shire’s velaglucerase alfa through pre-approval access programs.
Shire is based in England and has facilities in Cambridge and Lexington.
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