Generic drugmaker Teva Pharmaceutical Industries Ltd. (TEVA) Monday said its drug Lonquex, intended for reduction of chemotherapy-induced neutropenia, was recommended by the Committee for Medicinal Products for Human Use, or CHMP, for a marketing authorization in the European Union.
The firm looks forward to a final approval from the European Commission to offer the medication to patients.
Lonquex, or XM22 lipegfilgrastim, is used for reduction in duration of neutropenia and incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy.
Neutropenia is a common and potentially hazardous complication of chemotherapy characterized by a decreased level of white blood cells known as neutrophils, which can expose the patient to serious bacterial infections.
Lonquex is a long-acting recombinant granulocyte colony-stimulating factor based on novel GlycoPEGylation technology.
Lipegfilgrastim is a novel, pegylated and glycosylated long-acting form of filgrastim, intended for once-per-cycle fixed dose, subcutaneous injection for neutrophil support in patients receiving myelosuppressive chemotherapy with the exception of chronic myeloid leukemia and myelodysplastic syndromes.
Michael Hayden, president of Global R&D and chief scientific officer of the company said, "Effective prophylaxis against neutropenia and febrile neutropenia is a high priority for patients undergoing cytotoxic chemotherapy. This chemotherapy attacks rapidly dividing bone marrow cells and dramatically reduces the ability to fight off infection, which can have serious consequences for patients. Loquenex reduces the neutropenia that can lead to these consequences."
According to Teva, the positive opinion from CHMP is an important milestone in its efforts to provide new treatment options for patients in oncology, and opens the way to a final approval decision from the European Commission, anticipated within the next few months.
TEVA closed Friday's regular trading at $38.20 on the NYSE.
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