FDA Approves Teva’s Self-Administered Tbo-FilgrastimBy
Teva Pharmaceutical Industries Ltd. has received approval from the US Food and Drug Administration (FDA) for Granix (tbo-filgrastim) injection for self-administration by patients and caregivers. The approval of this additional administration option allows physicians the flexibility to prescribe Granix for either in-office or at home use.
Granix, a leukocyte growth factor, is indicated for reduction in the duration of severe neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. It has been commercially available in the US since November 2013. The currently marketed Granix syringe is indicated only for administration by a healthcare professional. Teva plans to launch a new Granix syringe, for self-administration by patients and caregivers, in early 2015.
In 2012, the FDA approved Teva’s (via Sicor Biotech)’s original biologics license application for tbo-filgrastim to reduce the time certain patients receiving cancer chemotherapy experience severe neutropenia, a decrease in infection-fighting white blood cells called neutrophils. Tbo-filgrastim was approved as an original biologics license application not as as a biosimilar to Amgen’s Neupogen (filgrastim), which is a previously licensed biological product that contains a related drug substance.
Source: Teva Pharmaceutical Industries