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    Emicizumab (RG6013, ACE910)

    Modality: Bispecific monoclonal antibody

    Disease State: Type 3 von Willebrand disease

    Summary

    Bispecific monoclonal antibody that restores coagulation by replacing the cofactor function of missing or deficient activated FVIII1,2

    VWD = von Willebrand disease

    Clinical Trials

    Type VWD
    Phase Enrollment Status Title
    Phase III Recruiting A study to assess the efficacy and safety of emicizumab in participants with Type 3 VWD, including randomized arms (Arms A and B) to compare emicizumab prophylaxis vs on-demand standard of care therapy, and an intraparticipant analysis (Arm C) of patients on prior SOC prophylaxis who switch to emicizumab prophylaxis (WILL-EMI) View Details
    Non-interventional study Recruiting An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment (WILL-EMI NIS) View Details

    VWD = von Willebrand disease

    Proposed Mechanism of Action

    Emicizumab, a bispecific monoclonal antibody, bridges activated factor IX and factor X to restore the function of missing activated factor VIII that is needed for effective hemostasis.1,2

    As emicizumab has no structural relationship or sequence homology to FVIII, it does not induce FVIII inhibitors and is not affected by the presence of FVIII inhibitors. Emicizumab is administered by subcutaneous injection1,2,3

    1. Kitazawa T, Shima M. Emicizumab, a humanized bispecific antibody to coagulation factors IXa and X with a factor VIIIa-cofactor activity. Int J Hematol. 2019;109(1):9-20. doi:10.1007/​s12185-018-2545-9
    2. Kitazawa T, Igawa T, Sampei Z, et al. A bispecific antibody to factors IXa and X restores factor VIII hemostatic activity in a hemophilia A model. Nat Med. 2012;18(10):1570-1574. doi:10.1038/​nm.2942
    3. Teranishi-Ikawa Y, Soeda T, Koga H, et al. A bispecific antibody NXT007 exerts a hemostatic activity in hemophilia A monkeys enough to keep a nonhemophilic state. J Thromb Haemost. 2024;22(2): 430-440;

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    TOP

    • NIS
      Non-interventional study

    • VWD
      von Willebrand disease