Glucarpidase should soon be approved throughout Europe to treat methotrexate toxicity.
The European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) recently recommended the approval of glucarpidase as a rescue therapy to reduce high-dose plasma methotrexate concentrations in adults and children.
The "positive opinion" is based on clinical data and real-world experience in the US, where glucarpidase (Voraxaze, SERB and BTG Specialty Pharmaceuticals) has been approved since 2012 and used to treat an estimated 2867 patients to date, according to a press release.
The potentially life-saving agent has been studied in four open-label multicenter studies of patients with delayed methotrexate elimination and, as reported by Medscape Medical News , has been shown to reduce methotrexate concentrations by up to 99% within 15 minutes of administration.
New data from Spain also show that 11.6% of patients treated with high-dose methotrexate can expect to develop acute kidney injury and an estimated 4.2% of affected patients will die. These findings, which are in line with prior results, were presented December 1 at the Virtual ISPOR Europe 2021 global conference on healthcare economics and outcomes.
The data will support the drug manufacturer's application for marketing approval for glucarpidase in the European Union. The application was submitted to the EMA in August 2020, prior to the merger between BTG and SERB in March 2021.
CHMP's nod of approval follows news that Japan also authorized sales of glucarpidase earlier this year. The drug will be marketed there as Megludase by BTG's marketing partner, Ohara Pharmaceutical, the company said.
Sharon Worcester is an award-winning medical journalist at MDedge News, part of the Medscape Professional Network
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Cite this: Glucarpidase Moves Toward European Approval as Rescue Therapy for Methotrexate Toxicity - Medscape - Dec 10, 2021.