BTG Specialty Pharmaceuticals Advances Global Regulatory Program for Glucarpidase, Sold as Voraxaze in US

BTG Specialty Pharmaceuticals

WEST CONSHOHOCKEN, PA — BTG Specialty Pharmaceuticals announced that Ohara Pharmaceutical Co., Ltd. recently obtained marketing authorization for glucarpidase from Japan’s Ministry of Health, Labour and Welfare as a therapeutic agent for “detoxication in case of delayed methotrexate elimination with methotrexate-leucovorin rescue therapy,” on September 28, 2021. Ohara will sell glucarpidase in Japan with the branded name Megludase®.

The Japanese Ministry of Health, Labour and Welfare granted this authorization based on the efficacy and safety results of clinical studies conducted in Japan and overseas, including an investigator-initiated study known as CPG2-PII funded by the Japan Medical Association. Ohara has been responsible for the glucarpidase development program and registration in Japan under a 2011 licensing agreement with BTG.

Christon Hill, Vice President for Product Life Cycle Management, said: “There is an acute need for reliable rescue therapy for toxic methotrexate concentration in patients with delayed clearance due to impaired renal function. As we continue to achieve regulatory milestones that broaden the availability of glucarpidase globally, we grow more excited for Voraxaze’s potential to improve the care of cancer patients around the world.”

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In August of 2020 BTG submitted a Marketing Authorisation Application for Voraxaze® (glucarpidase) with the European Medicines Agency (EMA) for the treatment of adults and children (from 28 days of age) at risk of methotrexate toxicity due to delayed methotrexate elimination. The EMA is reviewing the application under the centralized marketing authorization procedure. If approved Voraxaze® would receive marketing authorization in all member states of the European Union (EU), as well as in Iceland, Liechtenstein and Norway.

Marketed by BTG as Voraxaze® in the US, the US Food and Drug Administration granted marketing approval to glucarpidase in 2012. In the US, Voraxaze® is a carboxypeptidase indicated to reduce toxic plasma methotrexate concentration (greater than 1 micromole per liter) in adult and pediatric patients with delayed methotrexate clearance (plasma methotrexate concentrations greater than 2 standard deviations of the mean methotrexate excretion curve specific for the dose of methotrexate administered) due to impaired renal function.

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Voraxaze® is also being independently studied in Europe and the US to explore whether routinely giving Voraxaze® in combination with high-dose methotrexate might alleviate toxicity, manage the risk to patients and help them to complete therapy. Enrollment in these studies is ongoing. For more information about these studies, or to contact an investigator about participation, please visit ClinicalTrials.gov.

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