US FDA delays Teva's Neutroval BLA; custirsen enters second Ph III trial

4 October 2010

The US Food and Drug Administration has issued a Complete Response Letter for the Biologic License Application for Israeli drugmaker Teva Pharmaceutical Industries’ (Nasdaq; TEVA) Neutroval (granulocyte colony-stimulating factor) for the reduction in the duration of severe neutropenia and the incidence of febrile neutropenia in patients treated with established myelosuppressive chemotherapy for cancer.

The FDA requested additional information to complete the review of applications for approval of the product, which is Teva’s version of Amgen’s Neupogen, and means that Neutroval’s appearance on the market will be delayed.
The Complete Response Letter related to the Neutroval application requested several items which Teva is reviewing and will work with the FDA to determine the appropriate next steps regarding this application. This letter does not require additional pre-marketing clinical trials to complete the review of the BLA.

Teva and OncoGenex initiate second Ph III trial of custirsen in men with metastatic prostate cancer

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