This marketing application is being made for the interventional use of Voraxaze for the rapid and sustained reduction of methotrexate (MTX) in patients who have toxic MTX levels due to impaired renal function, said Protherics.
The development program for interventional use of Voraxaze has been granted fast track designation by the FDA, enabling the submission of the licensing application in sections rather than all components simultaneously.
The Voraxaze rolling biologics license application (BLA) commenced with the submission of a preclinical data module. The remaining two modules containing the chemistry, manufacturing and control (CMC) and clinical data are scheduled for submission within the next 12 months, as stipulated by the FDA.
Protherics intends to seek a priority review, reducing the time for the BLA review from 10 to six months from submission of the final part of the application. This would allow a potential marketing approval in the US in 2010.
Andrew Heath, CEO of Protherics, said: “The initiation of the Voraxaze BLA submission represents a significant milestone towards enhancing our portfolio of niche, specialty pharmaceutical products. Approval by the FDA would provide an excellent opportunity for us to promote and sell this important product in the US, alongside CroFab and DigiFab when their US marketing rights are returned to us in 2010.”