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Designed for efficacy in acquired hemophilia A (AHA)1

OBIZUR, Antihemophilic Factor (Recombinant), Porcine Sequence, temporarily replaces the inhibited endogenous factor VIII that is needed for effective hemostasis in patients with acquired hemophilia A.1 There have been no confirmed reports of viral transmission with recombinant factor VIII treatments. Additionally, OBIZUR contains no human or animal plasma.1

Indication

OBIZUR, Antihemophilic Factor (Recombinant), Porcine Sequence, is a recombinant DNA derived, antihemophilic factor indicated for the treatment of bleeding episodes in adults with acquired hemophilia A.1

Limitations of Use:

  • Safety and efficacy of OBIZUR has not been established in patients with baseline anti-porcine factor VIII inhibitor titer greater than 20 BU
  • OBIZUR is not indicated for the treatment of congenital hemophilia A or von Willebrand disease

Unmet needs in AHA treatment2

1
The ability to measure treatment effects with an objective surrogate marker for hemostasis1
2
A fast response that can be confirmed after initial and all subsequent dosing1
3
Safety No related thrombotic events reported3

The first interventional, prospective, open-label clinical trial for acquired hemophilia A measuring hemostatic response1

Clinical trial information

  • Hemostatic response was assessed at specified time points after initiation of OBIZUR treatment based on 2 combined factors1:
    • A prespecified rating scale that was based on clinical assessments
    • Objective factor VIII (FVIII) activity levels achieved
  • Of the 29 subjects, one subject was considered evaluable at study entry; however, it was later determined that this subject did not have AHA, leaving 28 subjects evaluable for efficacy1
  • Trial Design1,3
    Adults treated with OBIZUR
    (N=29)
    Hospitalized for serious bleeding episodes
     
    OBIZUR treatment initiated
    Initial dose:
    200 units/kg
     
    Assessed every hours
    Clinical improvement and FVIII activity levels
    Subsequent doses based on FVIII activity levels and clinical assessment
     
    24 hours after initiation
    Assessment of efficacy and safety
    Trial Design1,3
    Adults treated with OBIZUR
    (N=29)
    Hospitalized for serious bleeding episodes
     
    OBIZUR treatment initiated
    Initial dose: 200 units/kg
     
    Assessed every 2-3 hours

    Clinical improvement and FVIII activity levels

    Subsequent doses based on titration of FVIII activity levels and clinical assessment

     
    24 hours after initiation
    Assessment of efficacy and safety
    • Inhibitory antibodies against OBIZUR were measured using the Nijmegen modification of the Bethesda assay method1
    • Nearly all subjects received concomitant immunosuppressive treatments3

Inclusion and exclusion criteria

    Studied in a range of patients1

    Population Included

    Adults with
    • AHA
    • Autoimmune inhibitory antibodies to human FVIII
    • Serious bleeding episodes requiring hospitalization

    Population Excluded

    Adults with
    • Prior history of bleeding disorders other than AHA
    • Inhibitory antibodies against antihemophilic FVIII (recombinant), porcine sequence >20 Bethesda Units (BU)*
    • Bleeding episodes likely to resolve on their own
    *
    One BU=amount of an inhibitor that will neutralize 50% of 1 unit of FVIII in normal plasma after 120 minutes of incubation at 37°C.4

Patient characteristics

    OBIZUR Clinical Study Subject Characteristics (N=29)1
    Sex (n)
    Male 19
    Female 10
    Age range (Average Patient Age: 70 Years)  
    40-65 years 10
    ≥65 years 19
    Race  
    Caucasian 18
    African-American 6
    Asian 5
    Treatment-causing episode  
    Intramuscular/joint bleeding episodes 19
    Postsurgical bleeding episodes 4
    Intracranial bleeding episodes 2
    Surgery 2
    Retroperitoneal hemorrhage 1
    Periorbital bleed 1
    Anti-hemorrhagic treatment exposure prior to OBIZUR (n=28)  
    No immediate agents received 17
    Anti-hemorrhagics received (eg, rFVIIa, aPCC, TXA) 11