Posted by Michael Wonder on 18 Aug 2020
European Medicines Agency has accepted for review a marketing authorisation application for Voraxaze
17 August 2020 - BTG Specialty Pharmaceuticals, today announced the EMA has accepted for review a marketing authorisation application for Voraxaze (glucarpidase).
BTG Specialty Pharmaceuticals is seeking marketing authorisation of Voraxaze for the treatment of adults and children (from 28 days of age) at risk of methotrexate toxicity due to delayed methotrexate elimination.
The application for Voraxaze is based on clinical data as well as real world experience in the US, where glucarpidase was approved by the FDA in 2012.
