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Aug 30, 2012

FDA Clears First New G-CSF Neutropenia Therapy in 10 Years

  • FDA approved Teva Pharmaceuticals’ short-acting recombinant G-CSF product tbo-filgrastim (XM02 filgrastim) for reducing the duration of severe neutropenia in patients with nonmyeloid cancers receiving chemotherapy that impacts on the bone marrow. Teva says tbo-filgrastim is the first new G-CSF to be sanctioned in the U.S. for over 10 years.

    Filgrastim is already marketed in Europe under the trade name Tevagrastin®, a biosimilar of Neuopogen®. However, FDA submission of tbo-filgrastim was made as a Biologics License Application, as a biosimilar approval pathway hadn’t been established at the time of filing, Teva notes.

    Approval in the U.S. was based on studies in which patients treated using tbo-filgrastim during their first 21-day chemotherapy cycle demonstrated a significantly reduced average duration of neutropenia, from 3.8 days (with placebo therapy) to 1.1 day.

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