BTG's Voraxaze gains first approval, in USA

The US Food and Drug Administration has approved UK headquartered BTG International’s (LSE: BGC) Biologics License Application (BLA) for Voraxaze (glucarpidase) to treat patients with toxic levels of methotrexate in their blood due to kidney failure, marking the first approval for the drug.

Louise Makin, chief executive of BTG, commented: “Voraxaze is the first product BTG has taken through to approval in the USA and we look forward to its launch over coming months. It will be sold by our existing specialty pharmaceuticals sales force, with the addition of a few extra personnel, alongside our established emergency room medicines, CroFab and DigiFab.”

Methotrexate is a commonly used cancer chemotherapy drug normally eliminated from the body by the kidneys. However, patients receiving high doses of methotrexate may develop kidney failure, the FDA noted. Voraxaze is an enzyme that rapidly reduces methotrexate levels by breaking the chemotherapy drug down to a form that can be eliminated from the body. Voraxaze is administered directly into a patient’s vein (intravenously).