Voraxaze is an adjunctive therapy for patients experiencing, or at risk of, toxicity from methotrexate, a widely used anti-cancer agent.
The company said that there will now be an expedited approval process with possible final approval in 2008. In November 2006, Protherics resubmitted its biologics license application to the FDA after the regulatory body requested additional manufacturing data.
In Europe the marketing application for Voraxaze was also deemed inadequate by the European Medicines Evaluation Agency which has identified the need for further information on manufacturing. Protherics now anticipates that approval in the EU could be granted from the second half of 2008, in line with the current expectations for approval in the US.
The FDA has also approved the first planned study which is due to start at the MD Anderson Cancer Center in 2007.
“The granting of fast track status for Voraxaze in the US underlines the importance of this emergency intervention therapy,” said Andrew Heath, chief executive of Protherics.