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BIIB031 (rFVIIIFc)
rFVIIIFc is a recombinant Factor VIII fused to the Fc domain of human immunoglobulin G, which replaces deficient clotting Factor VIII to restore hemostatic function in hemophilia A.
rFVIIIFc is a recombinant Factor VIII fused to the Fc domain of human immunoglobulin G, which replaces deficient clotting Factor VIII to restore hemostatic function in hemophilia A. Used for Hemophilia A (treatment and prophylaxis of bleeding episodes).
At a glance
| Generic name | BIIB031 (rFVIIIFc) |
|---|---|
| Also known as | ELOCTATE, efmoroctocog alfa, antihemophilic factor (recombinant), Fc fusion protein, recombinant coagulation factor VIII Fc fusion protein |
| Sponsor | Bioverativ Therapeutics Inc. |
| Drug class | Recombinant clotting factor (Factor VIII Fc fusion) |
| Target | Factor VIII / coagulation cascade |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
This fusion protein combines the coagulation activity of Factor VIII with the extended half-life properties conferred by the Fc domain, allowing for less frequent dosing. The Fc fusion reduces the immunogenicity and clearance of Factor VIII, improving pharmacokinetics while maintaining hemostatic efficacy in patients with Factor VIII deficiency.
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
- An Open Label Study to Determine the Safety and Efficacy of Replacement Factor VIII Protein (Known as rFVIIIFc) in Previously Untreated Males With Severe Hemophilia A (PHASE3)
- A Study to Evaluate Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Participants With Inhibitors Undergoing the First ITI Treatment (verITI-8 Study) (PHASE4)
- Pharmacokinetics of rFVIIIFc at Two Vial Strengths (PHASE1)
- Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Pediatric Subjects With Hemophilia A (PHASE3)
- Pharmacokinetics and Safety of rFVIIIFc Manufactured at 15,000 L (15K) Scale (PHASE3)
- Long-Term Safety and Efficacy of rFVIIIFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia A (PHASE3)
- Fc factOrs and Real-World hemophiliA Patient-ReporteD Outcomes
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:
- BIIB031 (rFVIIIFc) CI brief — competitive landscape report
- BIIB031 (rFVIIIFc) updates RSS · CI watch RSS
- Bioverativ Therapeutics Inc. portfolio CI