Teva announced that the FDA has approved Tbo-filgrastim (XM02 filgrastim injection solution), the first granulocyte colony-stimulating factor (G-CSF) to be approved in the United States in more than 10 years. Tbo-filgrastim is indicated to reduce the duration of severe neutropenia in patients with non-myeloid malignancies who are receiving chemotherapy that affects the bone marrow.
This approval was based on study data that showed Tbo-filgrastim 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 vs. 3.8 days for those receiving placebo.
Tbo-filgrastim is a short-acting recombinant form of G-CSF, a naturally occurring hormone that is produced by the body to stimulate the bone marrow to produce neutrophils. A recombinant form of G-CSF is used to treat cancer patients with neutropenia in order to stimulate the bone marrow to produce more white blood cells.
Tbo-filgrastim is a solution for subcutaneous injection and will be available as a single-use, preservative-free, prefilled syringe in 300mcg/0.5mL and 480mcg/0.8mL dosage strengths. Teva expects to launch this product as early as November 2013, in accordance with the settlement reached with Amgen.
For more information call (888) TEVA-USA or visit www.tevausa.com.