Posted by Michael Wonder on 30 Mar 2024
FDA Approves Medexus's supplemental biologics license application for Ixinity to treat haemophilia B in paediatric patients
26 March 2024 - Expanded indication includes patients under 12 years of age, based on Phase 3/4 data demonstrating safety and efficacy in previously treated patients in this age group.
Medexus Pharmaceuticals today announced that the US FDA recently approved Medexus's supplemental biologics license application for Ixinity [coagulation factor IX (recombinant)] for the on-demand, prophylactic, and peri-operative treatment of paediatric patients under 12 years of age with haemophilia B.
