The European Commission has granted marketing authorization for Teva Pharmaceutical Industries' Lonquex (lipegfilgrastim) to commercialize in all twenty eight countries of the European Union plus Norway, Iceland and Liechtenstein.
Indicated for the reduction of the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy, Lonquex is a long-acting recombinant granulocyte colony-stimulating factor (G-CSF) with the active ingredient lipegfilgrastim.
Lonquex is intended as a once-per-cycle fixed dose, subcutaneous injection for neutrophil support in cancer patients receiving myelosuppresive chemotherapy, according to the company.
Teva Specialty Medicines president and CEO Dr Rob Koremans said, "Lonquex is an alternative G-CSF treatment for helping manage neutropenia during myelosuppressive chemotherapy."
The company has conducted a full clinical development program of Lonquex, including pre-clinical to clinical in vivo studies, as part of the efficacy and tolerability assessment for use with chemotherapy patients.
