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Shire Presents Positive New Data at the 60th Annual American Society of Human Genetics (ASHG) for Patients with Type 1 Gaucher Disease
Date:11/4/2010

rial program is the largest and most comprehensive set of Phase III trials conducted to date for type 1 Gaucher disease.

More about VPRIV

VPRIV (velaglucerase alfa for injection) was approved by the US FDA as a hydrolytic lysosomal glucocerebroside-specific indicated for long-term enzyme replacement therapy for adult and pediatric patients with type 1 Gaucher disease on February 26, 2010. The European Commission also has granted marketing authorization for VPRIV (velaglucerase alfa), for the long-term treatment of type 1 Gaucher disease on August 26, 2010, making it available in 30 countries across Europe.

VPRIV is for patients who are treatment-naive as well as patients who have previously been treated with imiglucerase.

Important Safety Information

The most serious adverse reactions seen with VPRIV were hypersensitivity reactions. Infusion-related reactions were the most commonly observed adverse reactions in patients treated with VPRIV in clinical studies. The most commonly observed symptoms of infusion-related reactions were: headache, dizziness, low or high blood pressure, nausea, tiredness and weakness, and fever.  Generally the infusion-related reactions were mild and, in treatment-naive patients, onset occurred mostly during the first 6 months of treatment and tended to occur less frequently with time.  

All adult side effects of VPRIV are considered relevant to children (ages 4 to 17 years). Side effects more commonly seen in children compared with adult patients included: upper respiratory tract infection, rash, aPTT prolonged, and fever. The safety of VPRIV has not been established in patients younger than 4 years of age.

As with all therapeutic proteins, there is a potential for immunogenicity. In the clinical studies 1 of 54 treatment-naive patients treated with VPRIV developed IgG class antibodies.  It is unknown if the presence of IgG antibodies to VPRIV is associated wi
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