FDA delays Protherics' Voraxaze til 2008

UK drugmaker Protherics says that the US Food and Drug Administration has requested additional manufacturing data following its Biologicals License Application submission for Voraxaze (carboxypeptidase G2), a treatment for patients at risk of kidney damage from the toxic effects of the widely-used anticancer drug methotrexate.

As a result, Protherics has withdrawn the BLA with the intention of resubmitting once the additional data has been generated in 2007. In a pre-BLA meeting with the agency in April 2006, the FDA agreed to Protherics' submission and the company will be seeking further guidance from the FDA on the precise nature of the information it requires but expects that the data will be available during 2007.

Based on recent discussions with the agency, Protherics believes that Voraxaze would be eligible for a priority review, reducing the review time for the BLA from 10 to six months. Assuming a quick review, Protherics now anticipates that approval could be granted in the USA from the second half of 2008, depending on the FDA's exact requirements, rather than the second half of 2007.