UK drugmaker Shire has presented new data showing that switching to its Gaucher disease drug VPRIV (velaglucerase alfa for injection)) from US biotech firm Genzyme's Cerezyme (imiglucerase) is safe, in the wake of further manufacturing problems for the latter that have also caused supply shortages for its product, as reported by The Pharma Letter yesterday.
The new research was presented at the 2010 American College of Medical Genetics (ACMG) Annual Clinical Genetics Meeting in Albuquerque, New Mexico, yesterday. This is the first time that data from the switch over study (TKT-034) from Cerezyme to VPRIV was disclosed. The data conclude that adult and pediatric patients with patients with Type 1 Gaucher disease can safely be transitioned from imiglucerase (Cerezyme) to VPRIV and that clinical measures of disease remain stable over a 12 month period.
No patients in the trial (TKT-034) developed antibodies to velaglucerase alfa, including three patients who tested positive for anti-imiglucerase antibodies at their initial screening.
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