Pfizer (PFE), Protalix (PLX) Say Taliglucerase Alfa MAA Not Approved by EMA CHMP
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Pfizer Inc. (NYSE: PFE) and Protalix BioTherapeutics, Inc. (AMEX: PLX) announced that the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) has adopted an Opinion recommending against the Marketing Authorization of taliglucerase alfa, an enzyme replacement therapy (ERT) for the treatment of Gaucher disease. As part of its Opinion, the CHMP gave a positive risk-benefit assessment for taliglucerase alfa concluding that the benefits of the medicine outweighed its risks in the treatment of Type 1 Gaucher disease.
Despite the positive risk-benefit assessment, the Committee could not recommend Marketing Authorization due to Shire's velaglucerase alfa, which received prior Marketing Authorization with orphan drug designation for the same condition. Therefore, Shire's treatment has orphan market exclusivity in the European Union (EU) for ten years from the time of its authorization in August 2010. Pfizer pursued a request for derogation from Shire's orphan market exclusivity based on a number of factors. This request, however, was denied.
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Despite the positive risk-benefit assessment, the Committee could not recommend Marketing Authorization due to Shire's velaglucerase alfa, which received prior Marketing Authorization with orphan drug designation for the same condition. Therefore, Shire's treatment has orphan market exclusivity in the European Union (EU) for ten years from the time of its authorization in August 2010. Pfizer pursued a request for derogation from Shire's orphan market exclusivity based on a number of factors. This request, however, was denied.
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