14 January 2022 – SERB and BTG Specialty Pharmaceuticals announced that the European Commission has granted marketing authorisation for Voraxaze® (glucarpidase) to reduce toxic plasma methotrexate concentration in adults and children (aged 28 days and older) with delayed methotrexate elimination or at risk of methotrexate toxicity. Voraxaze® is now authorized for marketing in all members states of the European Union as well as Iceland, Liechtenstein, and Norway. It will be sold in these markets by SERB, which merged with BTG Specialty Pharmaceuticals in March 2021.
This marketing authorisation in the EU is a result of the positive opinion issued on 11 November by the European Medicines Agency’s Committee for Human Medicinal Products (CHMP). The authorisation is based on clinical data as well as real world experience in the US, where glucarpidase was approved by the FDA in 2012. Since its launch in the US, an estimated 2,867 patients have been treated with Voraxaze®. The efficacy of Voraxaze® has been evaluated in four open-label multi-center studies in patients with delayed methotrexate elimination due to renal dysfunction. In 169 patients with methotrexate concentrations measured by chromatographic methods, a median reduction of > 98% in methotrexate concentration occurred within 15 minutes following Voraxaze® administration.
About High Dose Methotrexate Toxicity
High Dose Methotrexate (HDMTX) chemotherapy is used to treat or prevent the recurrence of certain types of cancer in adults and children, such as leukaemia, lymphoma, and osteosarcoma. Despite standard supportive measures, HDTMX may induce renal dysfunction in some patients, delaying MTX elimination. This may result in sustained elevated levels of MTX concentration which in turn may cause acute renal toxicity and other systemic adverse reactions that do not respond to standard doses of first-line therapy.
Administering Voraxaze® may quickly lower MTX levels and avoid further systemic damage. 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 only drug able to reduce toxic plasma methotrexate levels.
Further Development of Voraxaze®:
In addition to the current indications, Voraxaze® is being independently studied in Europe and the United States to explore whether the “planned use” of Voraxaze® in combination with high-dose methotrexate might alleviate toxicity, manage the risk to patients, and help them to complete therapy. Enrolment in these studies is ongoing. For more information about these studies, or to contact an investigator about participation, please visit ClinicalTrials.gov.
About SERB and BTG Specialty Pharmaceuticals
Together, SERB and BTG are a growing specialty pharmaceutical company and a dedicated ally to healthcare providers treating patients with critical conditions, focusing on emergency care and rare diseases. For over 30 years we have made treating these complex and life-threatening conditions possible, supporting clinicians, healthcare systems and governments while offering hope to patients and their families. As a fully integrated company, we have the experience and capabilities to acquire, develop, and manufacture our medicines to the highest standards, and make them available worldwide through our secure supply chain.
Learn more about SERB: https://serb.eu/
Learn more about BTG Specialty Pharmaceuticals: btgsp.com.
For further information contact:
Chris Sampson, Corporate Communications Director
firstname.lastname@example.org; Mobile: +44 (0)7773 251 178