LONDON, November 30, 2021 / PRNewswire / – SERB and BTG Specialty Pharmaceuticals today announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a favorable opinion recommending marketing authorization for VoraxazeÂ® (glucarpidase) to reduce the toxic plasma concentration of methotrexate in adults and children (aged 28 days and older) with delayed elimination of methotrexate or at risk of methotrexate toxicity.
The positive opinion of the CHMP is one of the last steps before marketing authorization is granted by the European Commission, which has the power to approve medicines for use in all Member States of the European Union as well as Iceland, Liechtenstein, and Norway. VoraxazeÂ® will be sold in these markets by SERB, which merged with BTG in March 2021.
The EMA Committee for Orphan Medical Products (COMP) also recommended that VoraxazeÂ® remains registered in the Community register of orphan medicinal products. Orphan drugs benefit from 10 years of commercial exclusivity upon approval as well as regulatory support for subsequent clinical development and commercialization in the European Union.
“Prolonged exposure to high concentrations of methotrexate can cause serious and potentially fatal toxicity,” said Antoine Bernasconi, commercial director of SERB. âThis positive CHMP opinion for Voraxaze is an important step towards offering a reliable and specific rescue treatment for cancer patients in Europe which have toxic levels of methotrexate. “
The positive opinion is based on clinical data as well as real world experience in the United States where VoraxazeÂ® has been sold by BTG Specialty Pharmaceuticals since it was approved by the FDA in January 2012. Since its launch in the United States, approximately 2,867 patients have been treated with VoraxazeÂ®. The effectiveness of VoraxazeÂ® has been evaluated in four open-label, multicentre studies in patients with delayed elimination of methotrexate. In patients with methotrexate concentrations measured by chromatographic methods, a median> 97% reduction in methotrexate concentration occurred within 15 minutes of Voraxaze.Â® administration. [i], [ii]
The CHMP’s approval follows the announcement earlier this year that from Japan The Department of Health, Labor and Welfare has authorized the sale of glucarpidase in Japan like MegludaseÂ® by BTG’s marketing partner, Ohara Pharmaceutical Co.
About the toxicity of high-dose methotrexate
High-dose methotrexate chemotherapy (HDMTX) is used to treat or prevent the recurrence of certain types of cancer in adults and children, such as leukemia, lymphoma, and osteosarcoma. Despite standard supportive measures, HDTMX may induce renal dysfunction in some patients, delaying the elimination of MTX. This can lead to sustained high levels of MTX concentration which in turn can cause acute kidney toxicity and other systemic adverse effects that do not respond to standard doses of first-line therapy.
Administration of VoraxazeÂ® can quickly lower MTX levels and prevent further systemic damage. It works by breaking down methotrexate into its inactive metabolites which are then eliminated from the body through pathways other than the kidneys, primarily the liver. VoraxazeÂ® is the only drug capable of reducing toxic plasma levels of methotrexate.
Further development of VoraxazeÂ®:
In addition to the current indications, VoraxazeÂ® is the subject of an independent study in Europe and United States to explore whether the “intended use” of VoraxazeÂ® in combination with high dose methotrexate may reduce toxicity, manage risk to patients and help them complete treatment. Registration for these studies is in progress. For more information on these studies or to contact a researcher 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 of healthcare providers who treat patients with critical conditions, with a focus on emergency care and rare diseases. For more than 30 years, we’ve made the treatment of these complex and life-threatening illnesses possible, supporting clinicians, healthcare systems and governments while providing 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 globally through our secure supply chain.
Learn more about SERB: https://serb.eu/
Learn more about BTG Specialty Pharmaceuticals: https://btgsp.com.
For more information contact:
Chris Sampson, Director of Corporate Communications
[emailÂ protected]; Mobile: +44 (0) 7773 251 178
[i] Widemann BC, Balis FM, Kim A, et al. Glucarpidase, Leucovorin, and Thymidine for High Dose Methotrexate-Induced Renal Dysfunction: Clinical and Pharmacological Factors Affecting Outcome. J Clin Oncol. 2010; 28 (25): 3979-3986.
[ii] North American Congress of Clinical Toxicology (NACCT) 2013 Annual Meeting. Clin Toxicol. 2013; 51 (7): 575-724.
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SOURCE SERB Specialty pharmaceutical products; BTG Pharmaceutical Specialties