Teva Announces FDA Approval of Granix for Self-Administration

Teva Pharmaceuticals announced on Dec. 23, 2014 that it received FDA approval of Granix (tbo-filgrastim) for self-administration for the reduction in duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. Teva plans to launch the self-administered, pre-filled syringe in early 2015, as the currently marketed syringe is indicated only for use healthcare professional. According to Pharmaceutical Commerce, the trend toward self-administered drugs allows patients to play “a greater role in the delivery and management of their treatments,” however there is always the risk of patient injury if not administered correctly.

“In partnership with their physician, patients will be able to decide whether administering Granix via self-injection at home or by a healthcare professional is the right course for them. Selecting a course of self-administration may allow patients to consolidate the number of required visits to their physician and allow additional access for patients who have challenges in visiting their providers,” said Lee S. Schwartzberg, MD, FACP, division chief of hematology oncology at the University of Tennessee Health Science Center, in a press release.

Granix is a leukocyte growth factor and became commercially available in the US in November 2013. A settlement in 2011 between Amgen and Teva resulted in Teva agreeing not to market the product in the US until November 2013, even though it was approved by FDA in 2012. Teva submitted a biologics license application (BLA) to FDA before a biosimilar pathway was available. At the time, Amgen’s treatment for the same indication, Neupogen (filgrastim), had already been marketed commercially in the US for over a decade. The BLA application allowed Teva to market tbo-filgrastim in the US not as a biosimilar (as it was approved in the EU under trade name Tevagrastim), but as a “related drug substance” for similar indications.

The safety of the drug was evaluated in three Phase III clinical trials in patients receiving myelosuppressive chemotherapy for breast cancer, lung cancer, and non-Hodgkin’s lymphoma. In the studies, there was a 71% reduction in the duration of severe neutropenia when compared with placebo. The efficacy of the drug was evaluated a multinational, multicenter, randomized, controlled Phase III study of chemotherapy-naïve patients with high-risk stage II, stage III, or stage IV breast cancer receiving a myelosuppressive regimen of doxorubicin (60 mg/m² IV bolus) and docetaxel (75 mg/m²).

Sources:
Teva Pharmaceuticals First Word PharmaGranixRX