Teva Pharmaceutical Industries is filing a Biologics License Application (BLA) with the US Food and Drug Administration (FDA) for XM02, a new drug to prevent neutropenia, a condition associated with low white blood cell counts in patients with diseases such as cancer.
XMO2 is a granulocyte colony-stimulating factor (G-CSF) for reduction of the duration of severe neutropenia and the incidence of febrile neutropenia in patients treated with established myelosuppressive chemotherapy for cancer.
Neutropenia is a haematological disorder characterised by an abnormally low number of neutrophils, the most important type of white blood cell in the blood.
Teva’s BLA for XM02 was submitted to the FDA on 30 November 2009. The proposed trade name for XM02 is Neutroval.
In September 2008, XM02 received marketing authorisation in the 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.