Teva Pharmaceutical Industries Ltd, announced the submission of a Biologics License Application (BLA) with the US Food and Drug Administration (FDA) for XM02, a granulocyte colony-stimulating factor (G-CSF) for the reduction in the duration of severe neutropenia and the incidence of febrile neutropenia in patients treated with established myelosuppressive chemotherapy for cancer. XM02 was principally developed as a similar biological medicinal product to Neupogen, the trademark for filgrastim (G-CSF). In September 2008, XM02 received marketing authorization in the European Union (EU) where a biosimilars pathway exists. XM02 was launched in several EU markets under the trade name TevaGrastim and will be launched in additional EU markets over time.
Teva's BLA submission is based on results from a clinical programme consisting of five studies with more than 680 patients. The key study, conducted in breast cancer patients, was a three-arm study of XM02, Neupogen or placebo in the first cycle of chemotherapy. Two additional clinical trials evaluating safety and efficacy were conducted in lung cancer and Non-Hodgkin's Lymphoma patients, which compared XM02 and Neupogen during the first cycle of chemotherapy. These studies demonstrated the efficacy of XM02 with regard to the duration of severe neutropenia, incidence of febrile neutropenia and measure of absolute neutrophil count change over time which now needs to be reviewed by the US Food and Drug Administration.
"We are pleased to complete the BLA submission for XM02, and as a result, mark a U.S. milestone for us as it is our first biologic product. Our G-CSF product was the first G-CSF biosimilar product approved in Europe and we look forward to working closely with the FDA to bring this important treatment option to the US," William S Marth, president and chief executive officer of Teva North America stated. "Teva is dedicated to bringing high quality and affordable biologics to our customers, including a portfolio of additional follow on biologic drugs currently in research and development."