Posted by Michael Wonder on 03 Aug 2024
FDA has accepted a BLA for bentracimab, the first and only ticagrelor reversal agent, for filing and priority review
2 August 2024 - SFJ Pharmaceuticals, sponsor of the bentracimab biologics license application, and SERB Pharmaceuticals (SERB), who acquired exclusive US rights to bentracimab from SFJ and will commercialise bentracimab in the US, announced today that the US FDA has accepted the bentracimab BLA for filing and priority review with a target action date in Q1 of 2025.
The BLA submission is based on the planned second interim analysis results of the Phase 3 REVERSE-IT trial.
