BTG Plc (BGC.L) said it has received U.S. FDA approval for its Biologics License Application or BLA for Voraxaze. The approval for Voraxaze, indicated for the treatment of toxic plasma methotrexate concentrations, was granted under priority review.
Chief Executive, Louise Makin, said: "Voraxaze is the first product BTG has taken through to approval in the US 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."
The company said the approval was based on the pharmacodynamic endpoint of a rapid and sustained clinically important reduction in plasma methotrexate concentration. All evaluable patients in the study exhibited over 95% reduction in methotrexate concentration from pre-treatment baseline levels that was maintained for up to 8 days following glucarpidase therapy.
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