On August 30, 2012 Teva reported that the U.S. Food and Drug Administration (FDA) has granted approval for tbo-filgrastim (XM02 filgrastim), the first new granulocyte colony-stimulating factor (G-CSF) to be approved in the United States in more than 10 years (Press release Teva, AUG 30, 2012, View Source [SID:1234500814]). Tbo-filgrastim is a short-acting recombinant form of G-CSF, indicated to reduce the duration of severe neutropenia in patients with certain types of cancer (non-myeloid malignancies) who are receiving chemotherapy that affects the bone marrow. Neutropenia is a condition in which the number of white blood cells is decreased, leaving patients more susceptible to potentially life-threatening bacterial infections.

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Teva currently markets filgrastim in Europe under the trade name Tevagrastim, a biosimilar to Neupogen. Tbo-filgrastim was filed in the U.S. as a Biologics License Application (BLA) since a biosimilar approval pathway had not been established at the time of submission. Teva will market tbo-filgrastim as early as November 2013, in accordance with the settlement reached with Amgen.

"As a company dedicated to bringing needed medicines to patients, we are delighted with the approval of tbo-filgrastim which offers physicians and their patients undergoing chemotherapy a new supportive care treatment option," said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer for Teva Pharmaceutical Industries Ltd. "The approval of tbo-filgrastim demonstrates Teva’s strong commitment to providing patients with new treatment options. It expands upon Teva’s existing Oncology portfolio with the addition of the first biologic and supportive care agent for oncology patients."

In studies of tbo-filgrastim, the drug was shown to have statistically significant reductions in the duration of severe neutropenia compared to placebo. During the first 21-day chemotherapy cycle, patients treated with tbo-filgrastim had severe neutropenia for an average of 1.1 days, compared with 3.8 days for those receiving placebo.