The Israeli Ministry of Health's marketing authorization of Elelyso was based on its review of data compiled by the Company from its pivotal phase III clinical trial, as well as data from its extension trial in which treatment-naïve patients that were treated with taliglucerase alfa for a 24-month period, and from the Company's switchover trial which collected data from Gaucher patients that had previously been treated with imiglucerase (Cerezyme ®) and were switched to treatment with taliglucerase alfa (Elelyso)."The Israeli approval of Elelyso is important for local Gaucher patients," said Mr. Yossi Cohen, Chairman of the Israeli Association for Gaucher. "Given the inconsistent supply of ERT for the treatment of Gaucher disease worldwide in recent years, we believe the addition of a new treatment for Gaucher patients will provide them with greater confidence regarding treatment. The fact that the product is manufactured locally by an Israeli company increases our excitement about this approval."
Protalix BioTherapeutics Receives Marketing Authorization For Elelyso(TM) For The Treatment Of Gaucher Disease From The Israeli Ministry Of Health
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