OGS' Vevesca is under review by EMEA
Oxford GlycoSciences has filed for approval of its Gaucher diseasetreatment Vevesca (OGT 918) with the European Medicines Evaluation Agency, which has accepted the dossier for review. The submission includes data on the use of the drug as oral monotherapy, in combination with Genzyme's Cerezyme (imiglucerase) and as switch/maintenance therapy after initial Cerezyme treatment. The company has also said that it is currently filing for approval in the USA using the "rolling" New Drug Application procedure, and this process should be completed "in the coming weeks." The drug is slated for fast-track review in the USA.
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