This approval provides the regulatory framework for the commercialization of Lonquex in all 28 EU countries.
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Teva Pharmaceutical Industries Ltd (NYSE: TEVA) announced today that the European Commission has granted marketing authorization for Lonquex (lipegfilgrastim).
This approval provides the regulatory framework for the commercialization of Lonquex in all 28 countries of the European Union plus Norway, Iceland and Liechtenstein.
Lonquex is a long-acting recombinant granulocyte colony-stimulating factor with the active ingredient lipegfilgrastim, which reduces side effects during chemotherapy treatment for cancer. Lonquex 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).
Teva Specialty Medicines president and CEO Dr. Rob Koremans said, “This is an important milestone for Teva Specialty Medicines in Europe and demonstrates our commitment to making a difference to the lives of those with cancer. Lonquex is an alternative G-CSF treatment for helping manage neutropenia during myelosuppressive chemotherapy. The European approval comes earlier than expected, just 8 weeks after the positive CHMP opinion. We look forward to providing this oncology supportive care treatment option in all European Union member states.”
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.
Teva’s president of global R&D and chief scientific officer, Dr. Michael Hayden said, “Effective prevention and treatment of febrile neutropenia is an important consideration for clinicians managing cancer patients who are undergoing cytotoxic chemotherapy. As well as targeting cancer cells, chemotherapy affects rapidly-dividing bone marrow cells, thereby dramatically reducing a patient’s ability to fight off infection, with potentially serious consequences. This approval is testament to Teva’s commitment to bringing new and alternative treatments to market to support clinicians in caring for patients.”