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. 

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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. 

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