Product
Voraxaze™
glucarpidase
Voraxaze™ Emergency Enquires:
Europe/RoW:
David Briscoe: Tel: +44 (0)20 7246 9950 / 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 and US LV PK: AAIPharma: +1 866 918 1731
US intrathecal: BTG/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 also 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. Marketing applications were previously submitted in the US and EU and subsequently withdrawn following requests for additional information. To support marketing applications in the US and EU, BTG is undertaking a small clinical study, the leucovorin pharmacokinetic (LV PK) interaction study, to further characterise the drug-drug interaction between Voraxaze™ and leucovorin. This study is being conducted alongside the completion of additional manufacturing and analytical work. Three consecutive conformance batches of Voraxaze™, which are required for regulatory approval, are currently being manufactured.
BTG (formerly as Protherics) has started resubmitting a Biological License Application (BLA) to the US Food and Drug Administration (FDA) on a rolling basis. We intend 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 2010. Following feedback from the EMEA, 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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