Drug intelligence / Profile preview

pd-FVIIa + FX

Development stage
Unknown
Lead developer
KM Biologics
Modality
Recombinant Proteins and Enzymes
Administration
Intravenous
01

Overview

pd-FVIIa + FX is a plasma-derived bypassing agent consisting of activated coagulation factor VII (FVIIa) and factor X (FX) at a fixed protein weight ratio of 1:10, developed as a hemostatic treatment for patients with hemophilia A or B with inhibitors and for acquired hemophilia A, particularly in Japan.[1][2][4][7] By supplying both FVIIa and its substrate FX, the product enhances tissue factor–mediated activation of FX to FXa and thereby augments thrombin generation and clot formation even in the absence or inhibition of factor VIII or IX, improving ex vivo and in vitro coagulation parameters more consistently than recombinant FVIIa alone or activated prothrombin complex concentrates in some models.[1][2][7] Clinical and perioperative studies have shown that this plasma-derived FVIIa/FX mixture (marketed in Japan as Byclot and also studied under the code MC710) is effective and generally well tolerated for on-demand treatment and perioperative management of bleeding in inhibitor-positive hemophilia and acquired hemophilia patients.[1][2][3][4]

Brand names
Byclot
Other names
pd-FVIIa/FXplasma-derived FVIIa/FXplasma-derived factor VIIa and factor X mixtureFVIIa/FXpd-FX/FVIIa
02

Targets

F10 (Factor Xa)F3 (Tissue factor)

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