Glucarpidase Approval in Europe for Methotrexate Toxicity in View
Glucarpidase is likely to be approved in Europe in the near future to treat methotrexate toxicities.
The European Medicine Agency’s Committee on Medicinal Products for Human Use(CHMP) has recently suggested that glucarpidase is approved as an emergency treatment to lower Methotrexate plasma concentrations at high doses in adults and children.
The “positive opinion” is based on clinical data and real-world experiences in the US, where glucarpidase (Voraxaze, SERB and BTG Specialty Pharmaceuticals) has been approved since 2012 and used to treat a total of 2867 patients according to a press announcement.
The life-saving drug has been studied in four open-label multicenter research studies of patients who suffer from delayed elimination of methotrexate. It as reported by Medscape Medical News it has been demonstrated to decrease methotrexate concentrations by as much as 99% within 15 minutes of administration.
New data from Spain also show that 11.6% of patients treated with high-dose methotrexate could develop acute kidney injury and an estimated 4.2% of affected patients will die. These findings, which are in line with previous results, were presented December 1 at the Virtual ISPOR Europe 2021 global conference on healthcare economics and outcomes.
The data will help 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, ahead of the merger between BTG and SERB in March 2021.
The CHMP’s approval comes after the news that Japan also authorized the sale of glucarpidase earlier in the year. Ohara Pharmaceutical, BTG’s marketing partner said that the drug will be sold in Japan under the name Megludase.
Sharon Worcester, a medical journalist at MDedge News and part of the Medscape Professional Network, is a multi-award winning journalist.
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