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Teva Pharmaceutical Industries Ltd Receives European Marketing Authorization For Lonquex (XM22 lipegfilgrastim)


Thursday, 8 Aug 2013 10:29am EDT 

Teva Pharmaceutical Industries Ltd announced that the European Commission has granted marketing authorization for Lonquex (lipegfilgrastim). This approval provides the regulatory framework for the commercialization of Lonquex in all twenty eight countries of the European Union plus Norway, Iceland and Liechtenstein. Lonquex is a long-acting recombinant granulocyte colony-stimulating factor (G-CSF) with the active ingredient lipegfilgrastim - a glycoPEGylated (PEG; polyethylene glycol) filgrastim molecule. Lonquex (lipegfilgrastim) is indicated for the reduction of the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes). Lonquex is intended as a once-per-cycle fixed dose, subcutaneous injection for neutrophil support in cancer patients receiving myelosuppresive chemotherapy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes). Lonquex has undergone a full clinical development program, including pre-clinical to clinical in vivo studies, as part of the efficacy and tolerability assessment for use with chemotherapy patients.