Drug intelligence / Profile preview

simoctocog alfa + emicizumab

Development stage
Preclinical
Lead developer
Octapharma
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes
Administration
Intravenous, Subcutaneous
01

Overview

This is a combination therapy composed of **simoctocog alfa**, a B-domain-deleted recombinant human coagulation Factor VIII (rFVIII) produced in a human cell line, and **emicizumab**, a bispecific recombinant monoclonal antibody that mimics the co-factorial function of activated Factor VIII. Simoctocog alfa is used for the treatment and prevention of bleeding in patients with hemophilia A by replacing the missing or deficient FVIII and restoring hemostasis. Emicizumab facilitates coagulation by bridging activated Factor IX and Factor X, effectively mimicking the action of FVIII, and is used mainly for prophylaxis in hemophilia A patients (with or without inhibitors). The combination is used clinically in scenarios such as immune tolerance induction (ITI), surgery, and the management of breakthrough bleeding in hemophilia A—especially in patients receiving emicizumab prophylaxis. Clinical data indicate that this combination achieves effective hemostasis and enables tailored bleed control in pediatric and adult populations with severe hemophilia A[3][1].

02

Targets

F8 (Coagulation Factor VIIIa)F10 (Factor Xa)Coagulation Factor IXa

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