Product
Voraxaze™
glucarpidase
Voraxaze™ Emergency Enquiries:
Europe/RoW:
David Briscoe: Tel: +44 (0)20 7575 1561 / Mobile: +44 (0)7968 492 957
IDIS Customer Services:
UK & Republic of Ireland: +44 (0)1932 824100
Other EU countries: +44 (0)1932 824123
Out of hours emergency line: +44 (0)1932 824198
US:
US intravenous: Voraxaze Call Centre: +1-877-398-9829
US intrathecal: Protherics Inc: +1-888-327-1027
Voraxaze™ US Supplies
Availability
Please consult our Product Supplies page for specific information on a country by country basis on how to obtain Voraxaze™.
Product Information
Voraxaze™ is an investigational new drug that is available in the US under a treatment protocol for patients receiving high dose methotrexate (≥1g/m2) who are experiencing or at risk of, methotrexate toxicity. High dose methotrexate is used to treat or prevent the recurrence of certain types of cancer. Patients are considered at risk of methotrexate toxicity if they have impaired renal function, which can lead to a delay in methotrexate elimination, or have evidence of delayed elimination based on methotrexate levels. Voraxaze™ is available in Europe and elsewhere outside the US on a named patient basis. Voraxaze™ is not approved in any country, and safety and efficacy have not been established for any use.
Development Status
Intervention
Voraxaze™ was granted orphan drug status in both the US and Europe in 2003. Protherics has started submitting a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) on a rolling basis, the final component of which is anticipated to be submitted to the FDA by the end of 2010. To support marketing applications in the US and EU, Protherics has completed a small clinical study, the leucovorin pharmacokinetic (LV PK) interaction study, to further characterise the drug-drug interaction between Voraxaze™ and leucovorin. The study met its primary endpoint and demonstrated that when Voraxaze™ is co-administered with leucovorin, patients receive adequate exposure to the active isomer of leucovorin when leucovorin dosing is based on pre-Voraxaze™ methotrexate levels. Protherics intends to seek a Priority Review, reducing the time for the BLA review from ten to six months from submission of the final part of the application and providing a potential approval in the US in 2011. Following feedback from the EMA, we are investigating the availability of a suitable non-clinical model to generate data to support resubmission of a Marketing Authorisation Application in the EU.
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