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GEN News Highlights : Jan 18, 2012

FDA Clears BTG’s Voraxaze for Treating Methotrexate Toxicity

Therapy can be used in patients with impaired renal function.

FDA approved BTG’s Voraxaze® (glucarpidase) for the treatment of toxic plasma methotrexate concentrations in patients with delayed methotrexate clearance due to impaired renal function. Clearance in the U.S. was granted under priority review, and was based on data from 290 patients treated in two open-label multicenter studies. BTG says Voraxase is the first product BTG has taken through to approval in the U.S.

The trials provided pharmacodynamic data confirming that Voraxaze treatment leads to a rapid, sustained reduction in plasma methotrexate concentrations. Efficacy data from a subset of patients demonstrated that treatment led to more than a 95% reduction in methotrexate concentration from pretreatment baseline levels, which was maintained for up to eight days.

“Prolonged exposure to high levels of methotrexate can result in kidney and liver damage, severe mouth sores, damage to the lining of the intestine, skin rashes, and death due to low blood counts,” remarks Richard Pazdur, M.D., director of the Office of Hematology and Oncology ROducts at FDA’s Center for Drug Evaluation and Research. “Voraxaze is an important new treatment option for cancer patients aimed at preventing these toxicities associated with sustained high levels of methotrexate.”

Voraxase will be sold by BTG’s existing specialty pharmaceuticals sales force, alongside its established emergency room medicines, CroFab® (crotalidae polyvalent immune fab (ovine)) and DigiFab® (digoxin immune fab (ovine)). CroFab is an FDA-approved antivenom for treating bites by North American Crotalid snakes. DigiFab is an antidote for life-threatening digoxin (digitalis) toxicity or overdose, which has been approved in the U.S., U.K., Switzerland, and Canada.