Shortage Could Cause Early Access To Developmental Gaucher Disease Drugs
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Shire and Protalix BioTherapeutics' experimental Gaucher disease drugs could enter the market early to help offset likely treatment shortages created by manufacturing problems with the only enzyme replacement therapy currently approved for the orphan condition: Genzyme's Cerezyme
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The FDA approval of Shire's Vpriv (velaglucerase) means that Genzyme's Cerezyme (imiglucerase) finally has competition in the Gaucher disease space. But market analysts are strongly divided on whether velaglucerase or a pending Pfizer/Protalix drug will be better positioned to make a dent in Cerezyme's market share
Positive Phase III results for Shire's Gaucher drug Vela
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