UK-based pharmaceutical company BTG has received US Food and Drug Adminsitration (FDA) approval for its Voraxaze medication, which is used to treat patients suffering from toxic levels of methotrexate due to kidney failure.
The basis of the approval was due to results found in a study of 22 patients, which saw methotrexate levels fall below the critical threshold within 15 minutes of treatment, staying below that level for eight days afterwards. Of the 22 patients, ten achieved the standard and Voraxaze eliminated 95% of methotrexate in all patients in the study.
Voraxaze works by breaking down methotrexate into inactive metabolities, which are then removed from the body using organs other than the kidney. Prolonged exposure to high levels of methotrexate can result in kidney and liver damage, damage to the lining of the intestine and, in severe cases, death due to low blood counts.
BTG acquired Voraxaze through its 2008 merger with Protherics, and the drug represents the first treatment that the company has received approval for within the US.