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.

Previous articleNew Crohn’s Disease Approval for Humira
Next articleLife and Sino Sign Distribution and Development Pact