Genzyme Rival Fails to Get FDA Approval

2/25/11

The FDA has given a complete response letter to Israel-based Protalix Biotherapeutics for the company’s application for marketing approval of an protein therapy for Gaucher’s disease, the firm announced this morning. Cambridge, MA-based Genzyme currently has the best selling treatment for Gaucher’s disease, which is a rare genetic disorder that causes a fatty substance to build up in cells and organs. Protalix, which partnered with Pfizer in November 2009 to develop its Gaucher’s treatment, taliglucerase alfa, said that the FDA could not approve its drug at this time because of the agency’s questions about clinical matters, chemistry, manufacturing, and controls related to the  product.

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