Vpriv velaglucerase alfa: Additional Phase III data

Additional data from the double-blind, international Phase III HGT-GCB-039 trial in 34 treatment-naïve patients with Type I Gaucher's disease showed that 60 U/kg IV Vpriv every other week significantly increased lumbar spine bone mineral density (BMD), as measured by dual-energy x-ray absorptiometry (DEXA scan) Z-scores, from baseline to 9 months vs. Cerezyme imiglucerase. Specifically, Vpriv increased mean lumbar spine BMD Z-score from baseline to 9 months by 0.33 points vs. a reduction of 0.06 points for Cerezyme (p<0.05). Median baseline Z-scores were -1.46 points for the Vpriv group and -0.86 points for the Cerezyme group.

All patients who were enrolled into the open-label HGT-GCB-044 extension trial received 60 U/kg IV Vpriv every other week for an additional 15 months. At month 24, Vpriv increased lumbar spine BMD Z-scores to 0.64 in patients who received Vpriv in HGT-GCB-039 and to 0.54 points in patients who switched from Cerezyme at 9 months. Femoral neck BMD changes from baseline in both cohorts were non-significant (p>0.05) at both 9 and 24 months. Data were presented at the European Working Group on Gaucher Disease meeting in Paris. ...