Jivi (antihemophilic factor [recombinant] PEGylated-aucl) approved for the treatment of hemophilia A.
Jivi is a DNA-derived, factor VIII concentrate, approved for use in previously treated adults and adolescents – aged 12 years and older – with hemophilia A.
The product is also approved for on-demand treatment and control of bleeding episodes, for perioperative management of bleeding, and as routine prophylaxis to reduce the frequency of bleeding episodes.
The initial recommended prophylactic regimen is dosing twice weekly (30-40 IU/kg) with the ability to dose every 5 days (45-60 IU/kg) and to further individually adjust to less or more frequent dosing based on bleeding episodes.
Approval of Jivi is based on results from the phase 2/3 PROTECT VIII trial.
Engineered to have an extended half-life by harnessing proven PEG-technology.
Has a half-life of 17.9 hours that delivers sustained levels in the blood.