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Shire Announces FDA Approval of VPRIV(TM) (velaglucerase alfa for injection) for the Treatment of Type 1 Gaucher Disease
Date:2/26/2010

Clinical Trial Results

Shire's VPRIV clinical trial program included the largest and most comprehensive set of Phase III trials conducted to date for Gaucher disease.

The efficacy of VPRIV was assessed in three clinical studies in a total of 99 patients with type 1 Gaucher disease. Eighty-two patients age 4 years and older received VPRIV and 17 patients age 3 years and older received imiglucerase. Studies I and II were conducted in patients who were not currently receiving Gaucher disease-specific therapy. Study III was conducted in patients who were receiving imiglucerase treatment immediately before starting VPRIV. In these studies, VPRIV was administered intravenously over 60 minutes at doses ranging from 15 Units/kg to 60 Units/kg every other week. Each study met its primary endpoint.

Important Safety Information

The most serious adverse reactions seen with VPRIV were hypersensitivity reactions.


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SOURCE Shire Pharmaceutical
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Prepared by multi-temperature ethanol fractionation with extensive charcoal treatment and dialysis.• Assay: ≥ 95 % (HPCE)• pH ~5.2 (10 mg/mL in 0.15 M NaCl)...
Special grade: for electrophoresis...
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