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Factor VIII (rFVIIIFc)
rFVIIIFc is a recombinant Factor VIII protein fused to the Fc domain of human immunoglobulin G, which replaces deficient clotting Factor VIII to restore hemostasis in hemophilia A patients.
rFVIIIFc is a recombinant Factor VIII protein fused to the Fc domain of human immunoglobulin G, which replaces deficient clotting Factor VIII to restore hemostasis in hemophilia A patients. Used for Hemophilia A (treatment and prophylaxis of bleeding episodes).
At a glance
| Generic name | Factor VIII (rFVIIIFc) |
|---|---|
| Also known as | Recombinant Factor VIII Fc Fusion Protein |
| Sponsor | Bioverativ Therapeutics Inc. |
| Drug class | Recombinant clotting factor |
| Target | Factor VIII / Intrinsic tenase complex |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
Factor VIII is a critical blood coagulation protein that is deficient or dysfunctional in hemophilia A. The recombinant Factor VIII (rFVIII) is produced through genetic engineering, and the addition of the Fc domain extends the half-life of the protein in circulation, allowing for less frequent dosing compared to conventional Factor VIII products. This fusion protein restores the intrinsic coagulation pathway and enables normal thrombin generation.
Approved indications
- Hemophilia A (treatment and prophylaxis of bleeding episodes)
Common side effects
- Inhibitor development (anti-Factor VIII antibodies)
- Injection site reactions
- Headache
- Hypersensitivity reactions
Key clinical trials
- A 48-Month Study to Evaluate Long-Term Effectiveness of Elocta on Joint Health
- Pharmacokinetic Comparison of Efanesoctocog Alfa vs Other EHL-rFVIII Products in Participants With Severe Haemophilia A (PHASE1)
- Study to Provide Continued Access to Treatment for Patients Completing a Previous Trial With Efanesoctocog Alfa (PHASE3)
- A Study Evaluating Physical Activity and Joint Health in Severe Haemophilia A Patients ≥12 Years Treated Once Weekly With Efanesoctocog Alfa (PHASE3)
- A Phase 3 Open-label Interventional Study of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, Efanesoctocog Alfa (BIVV001), in Patients With Severe Hemophilia A (PHASE3)
- Safety, Efficacy and PK of BIVV001 in Pediatric Patients With Hemophilia A (PHASE3)
- Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A (PHASE3)
- A Study to Evaluate the Real-world Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |