15 June 2023 - Expanded indication would cover patients 12 years of age or younger, a population that comprises approximately one in three patients treated for haemophilia B in the United States.
Medexus Pharmaceuticals today announced that the US FDA recently accepted for review Medexus's supplemental biological 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.