Protherics files DigiFab with Health Canada

UK biopharmaceutical firm Protherics, which is focused on the fields of critical care and cancer, says that it has submitted a New Drug Submission to Health Canada for its digoxin antidote DigiFab. The company explained that it is seeking regulatory clearance for the drug as a treatment for potentially life-threatening digoxin toxicity or overdose, an indication for which it is already approved by the US Food and Drug Administration.

DigiFab is a preparation of ovine-derived antibody fragments (Fab), with each vial of the product containing 40mg of digoxin immune Fab that is capable of binding approximately 0.5mg of the toxin. In clinical studies, the drug reduced the amount digoxin present in the blood to undetectable levels in 93% of patients 23 hours after its administration. The London-headquartered firm added that its submission to Canadian regulatory authorities follows its agreement with Swiss drug major Roche which will see the product replace the latter's Digitalis-Antidot (Marketletter December 4, 2006).

Protherics said that, subject to a successful review, it expects to receive marketing approval from Health Canada in 2008, and added that similar clearance is anticipated in the UK and several other European countries before the end of the year.