Protalix Says COFEPRIS, Public Health Institute of Chile Grant Approval to UPLYSO for Type 1 Gaucher Disease

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Protalix BioTherapeutics, Inc.
PLX
announced today that the Mexican Federal Commission for the Protection against Sanitary Risk (COFEPRIS) and the Public Health Institute of Chile have both granted regulatory approval to UPLYSO™ (alfataliglicerase) for the long-term enzyme replacement therapy for adults with a confirmed diagnosis of Type I Gaucher disease. UPLYSO will be marketed in Mexico and Chile by Pfizer Inc., the Company's commercialization partner. UPLYSO is known as ELELYSO™ (taliglucerase alfa) outside of Latin America. Taliglucerase alfa was approved by the U.S. Food and Drug Administration in May 2012 and subsequently has been approved by Israel's Ministry of Health, Brazil's ANVISA and by the regulatory authorities of other countries.
Posted In: NewsFDA
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