Shire presents new data for Replagal and VPRIV; gets PUDFA date for Firazyr

Ireland-headquartered biopharma company Shire (LSE: SHP) presented new data for Replagal (agalsidase alfa) in patients with Fabry disease, and VPRIV (velaglucerase alfa for injection) in patients with type 1 Gaucher disease, at the 2011 American College of Medical Genetics' (ACMG) Annual Clinical Genetics Meeting, held in Vancouver, Canada, from March 16-20, 2011.

Data from clinical programs evaluating the safety of switching from Genzyme’s Fabrazyme (agalsidase beta) to Replagal and long-term safety and efficacy of switching from Cerezyme (imiglucerase; also from Genzyme) to VPRIV were presented.

Preliminary data from Shire's Replagal study 059 suggests that switching from Fabrazyme to Replagal 0.2mg/kg every other week is generally well tolerated. This ongoing study includes 70 Fabry patients in the USA under Shire's treatment protocol who were switched to Replagal during the continuing Fabrazyme supply shortage. The safety events observed in this study were similar to those seen historically in patients treated with Replagal.