On June 28, 2012, Shire issued a press release relating to VPRIV® (velaglucerase alfa for injection), its enzyme replacement therapy for Type 1 Gaucher disease. The press release reported on the presentation of exploratory data at a scientific conference held in Paris on that date. The data were derived from a 9-month, Phase III, multi-center, randomized non-inferiority study and its 15-month extension study, and showed VPRIV’s effect on selected markers of Gaucher-related bone disease against baseline. The press release also included data on Genzyme Corporation’s enzyme replacement therapy for Type 1 Gaucher disease, Cerezyme® (imiglucerase for injection).
Shire wishes to state:
VPRIV 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-naïve 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.
VPRIV is not available in all countries and prescribing information may differ between countries. Please consult your local prescribing information. Full prescribing information for VPRIV in the U.S. can be found at www.VPRIV.com.
For further information please contact:
+1 781 482 0999
+44 1256 894157
+44 1256 894 280
+1 484 595 9836