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rFVIIIFc
rFVIIIFc is a recombinant Factor VIII 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 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 (congenital Factor VIII deficiency) for routine prophylaxis and on-demand treatment of bleeding episodes.
At a glance
| Generic name | rFVIIIFc |
|---|---|
| Also known as | Eloctate, recombinant coagulation factor VIII Fc fusion protein, BIIB031, antihemophilic factor (recombinant) Fc fusion protein, efmoroctocog alfa |
| Sponsor | Bioverativ Therapeutics Inc. |
| Drug class | Recombinant clotting factor (Factor VIII replacement therapy) |
| Target | Factor VIII / FcRn (neonatal Fc receptor) |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
Mechanism of action
The drug combines the coagulation activity of Factor VIII with the extended half-life properties conferred by the Fc fusion, allowing for longer intervals between infusions. The Fc domain binds to the neonatal Fc receptor (FcRn), which recycles the protein and extends its circulating half-life compared to conventional Factor VIII products. This enables improved hemostatic control with reduced dosing frequency.
Approved indications
- Hemophilia A (congenital Factor VIII deficiency) for routine prophylaxis and on-demand treatment of bleeding episodes
Common side effects
- Inhibitor development (anti-Factor VIII antibodies)
- Injection site reactions
- Headache
- Arthralgia
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)
- To Assess the Pharmacokinetics and Safety and Tolerability of Efanesoctocog Alfa (BIVV001)in Adults With Type 2N and 3 Von Willebrand Disease (VWD) (PHASE1)
- 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)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- rFVIIIFc CI brief — competitive landscape report
- rFVIIIFc updates RSS · CI watch RSS
- Bioverativ Therapeutics Inc. portfolio CI