London, UK, 18 January 2012: BTG plc (LSE: BGC), the
specialist healthcare company, today announces that it has
received regulatory approval from the US Food and Drug
Administration (FDA) for its Biologics License Application
(BLA) for Voraxaze® (glucarpidase). The approval of
Voraxaze® was granted under priority review, a designation
that is given to therapies that offer major advances in
treatment or provide a treatment where there is no adequate
alternative therapy.
Voraxaze® is indicated for the treatment of toxic plasma
methotrexate concentrations (>1 micromole per liter) in
patients with delayed methotrexate clearance due to
impaired renal function. It works by breaking down
methotrexate into its inactive metabolites which are then
eliminated from the body by routes other than the kidney
(primarily the liver). Voraxaze® is the first and only drug
able to reduce toxic plasma methotrexate levels.
High dose methotrexate chemotherapy is used to treat or
prevent the recurrence of certain types of cancer, such as
osteosarcoma, leukemia, and lymphoma. Some patients treated
with methotrexate develop impaired kidney function, which
leads to the accumulation of toxic levels of methotrexate
in the blood and puts patients at risk of additional
toxicity.
The most common related adverse events in clinical trials
were paresthesia (a sensation of tingling or burning on the
skin), flushing, nausea, vomiting, hypotension and
headache.
Louise Makin, Chief Executive Officer of BTG, commented:
"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®."
Guenter R. Janhofer, Chief Medical Officer and Head of
Development at BTG, added: "Today's FDA approval of
Voraxaze® has the potential to help patients in the rare
event that they experience delayed methotrexate elimination
due to impaired renal function. In the clinical trials
which led to approval, patients achieved rapid and
sustained reductions in plasma methotrexate
concentrations."
Clinical Trials
The FDA approval is based upon data from 290 patients who
were treated in 2 single-arm, open-label, multicentre
trials.The median age was 17 years (1 month to 85 years),
64% were male, 32% had osteogenic sarcoma or sarcoma and
63% had leukemia or lymphoma.
The FDA approval was based on the pharmacodynamic endpoint
of a rapid and sustained clinically important reduction
(RSCIR) in plasma methotrexate concentration, defined as an
attainment of plasma methotrexate concentration
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- BTG plc : Voraxaze® (glucarpidase) receives US regulatory approval