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Orphan status of Vpriv blocks Pfizer/Protalix's Elelyso at CHMP

This article was originally published in Scrip

Executive Summary

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended that Pfizer/Protalix Biotherapeutics' type 1 Gaucher disease treatment Elelyso (taliglucerase alfa) be refused marketing authorisation. The problem is that Shire's Vpriv (velaglucerase alfa), which was authorised for Gaucher disease in August 2010, had been granted 10-year market exclusivity as an orphan drug, effectively blocking Elelyso from the European market.



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