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Shire Receives CHMP Positive Opinion for VPRIV(TM) (velaglucerase alfa) for the Treatment of Type 1 Gaucher Disease in the European Union
Date:6/25/2010

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Important Safety Information

The most serious adverse reactions in patients treated 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, hypotension, hypertension, nausea, fatigue/asthenia, and pyrexia. 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. Other commonly observed adverse reactions in [greater than or equal to]10% of patients were: abdominal pain, back pain, joint pain, upper respiratory tract infection, and activated partial thromboplastin time prolonged. Adverse reactions more commonly seen in pediatric patients (>10% difference) included upper respiratory tract infection, rash, activated partial thromboplastin time prolonged, and pyrexia.

In clinical trials one patient developed neutralizing antibodies.

About Gaucher Disease

Gaucher disease is an autosomal recessive disorder caused by mutations in the GBA gene which results in a deficiency of the lysosomal enzyme beta-glucocerebrosidase. This enzymatic deficiency causes an accumulation of glucocerebroside, primarily in macrophages. In this lysosomal storage disorder, clinical features are reflective of the distribution of Gaucher cells in the liver, spleen, bone marrow, and other organs. The accumulation of glucocerebroside in the liver and spleen leads to organomegaly. Presence of Gaucher cells in the bone marrow and spleen lead to cl
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SOURCE Shire plc
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10. Shire Submits European Marketing Authorization Application (MAA) for velaglucerase alfa for the Treatment of Type 1 Gaucher Disease
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