Protherics submits Voraxaze BLA to FDA

UK-based biopharmaceutical company Protherics says it has submitted a Biologics License Application to the US Food and Drug Administration for Voraxaze, its adjunctive agent for patients at risk of toxicity from methotrexate during cancer therapy. Patients with impaired renal function are considered high-risk for MTX toxicity as the condition can lead to a delay in elimination of the agent.

In trials conducted in Europe and the USA, Voraxaze has been shown to rapidly reduce MTX concentration in the blood of patients in whom its elimination has been delayed, thereby reducing the risk of increased toxicity due to prolonged exposure. Protherics added that the compound was also well tolerated, with only 8% of the 329 patients reporting adverse events that were related to its use.

If approved, the drug will be used initially as an intervention to treat patients experiencing toxicity. Eventually, however, the firm said that it may be of more benefit when used as a preventative measure to reduce the overall risk of damaging toxicity.