Bayer announced that the Food and Drug Administration (FDA) has approved Jivi (antihemophilic factor [recombinant] PEGylated-aucl) for use in previously treated adults and adolescents (≥12 years) with hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes
Treatment with Jivi, a recombinant DNA-derived factor VIII (FVIII) concentrate, replaces the reduced or missing FVIII and has a half-life of 17.9 hours. The unique step-wise prophylactic regimen allows Jivi to be administered initially twice weekly (30-40 IU/kg) with the ability to dose every 5 days (45-60 IU/kg), where the dosing frequency can be further adjusted based on bleeding episodes.
The approval was supported by data from the phase 2/3 international, open-label PROTECT VIII trial (N=126) that evaluated previously treated patients aged ≥12 years with severe hemophilia A. Part A investigated the pharmacokinetics, safety, and efficacy of Jivi as on-demand treatment for bleeds, and as a prophylactic at different dosing regimens. Part B was an optional extension study evaluating safety and efficacy of Jivi during major surgery that was available to patients who completed Part A.
The data showed protection against bleeds and safety up to a median of 1.9 years. The majority of adolescent and adult patients showed good tolerability of Jivi; headache, cough, nausea, and fever were the commonly reported adverse reactions.
Jivi will be available as a 500IU, 1000IU, 2000IU, and 3000IU lyophilized powder for solution in single-use vials.
For more information call (888) 842-2937 or visit Bayer.com.