Jivi (BAY94-9027, antihemophilic factor [recombinant] PEGylated-aucl) can be prescribed at different dosing frequencies depending on patient needs.
Patients with Hemophilia A are missing factor VIII (FVIII), which is responsible for blood clotting. Recombinant factor VIII (rFVIII) replacement therapy is the standard of care for the treatment of patients with Hemophilia A and has been used successfully for decades.
Approval by the US Food and Drug Administration (FDA) of a new form of rFVIII therapy from Bayer gives patients access to a treatment that can be integrated with their personal lifestyles and used at different frequencies according to their needs. Jivi (BAY94-9027, antihemophilic factor [recombinant] PEGylated-aucl), has been approved for the routine prophylactic treatment of hemophilia A in previously treated adults and adolescents 12 years of age or older.
Site-specific PEGylation gives Jivi a half-life of 17.9 hours, allowing for sustained levels of the drug in the bloodstream. Jivi is recommended to be administered two times per week as a prophylactic regimen but can be given more or less frequently based on bleeding episodes. Jivi is also approved for on-demand treatment and the perioperative management of bleeding. The approval was based on results of the Phase 2/3 PROTECT VIII trial, which demonstrated bleed protection and safety of up to a median of 1.9 years (range of 0-2.6 years).
Bayer has also submitted marketing authorization applications for BAY94-9027 for the treatment of hemophilia A in the European Union and Japan.