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Factor IX (rFIXFc)
Factor IX (rFIXFc) is a recombinant clotting factor IX fused to the Fc domain of human immunoglobulin G, which replaces deficient Factor IX to restore blood coagulation in hemophilia B patients.
Factor IX (rFIXFc) is a recombinant clotting factor IX fused to the Fc domain of human immunoglobulin G, which replaces deficient Factor IX to restore blood coagulation in hemophilia B patients. Used for Hemophilia B (Factor IX deficiency) — routine prophylaxis and on-demand treatment of bleeding episodes.
At a glance
| Generic name | Factor IX (rFIXFc) |
|---|---|
| Also known as | Recombinant Human Factor IX Fc Fusion Protein |
| Sponsor | Bioverativ Therapeutics Inc. |
| Drug class | Recombinant clotting factor (Factor IX fusion protein) |
| Target | Factor IX (coagulation cascade) |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
This fusion protein combines the catalytic activity of Factor IX with the extended half-life properties conferred by the Fc domain, allowing for less frequent dosing compared to conventional Factor IX products. The Fc fusion extends circulating half-life by approximately 2–3 fold, improving pharmacokinetics and reducing treatment burden in hemophilia B management.
Approved indications
- Hemophilia B (Factor IX deficiency) — routine prophylaxis and on-demand treatment of bleeding episodes
Common side effects
- Injection site reactions
- Inhibitor development (anti-Factor IX antibodies)
- Thrombotic events
- Headache
Key clinical trials
- An International Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B
- A Study to Evaluate the Real-world Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B
- A Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B in France
- Study to Determine the Safety and Efficacy of rFIXFc in Previously Untreated Males With Severe Hemophilia B (PHASE3)
- Factor Product Utilization and Health Outcomes in Patients With Hemophilia
- Study of Recombinant Factor IX Fc Fusion Protein (rFIXFc) in Participants With Hemophilia B (PHASE3)
- Study of Recombinant Coagulation Factor IX Fc Fusion Protein, BIIB029, in Previously Treated Pediatric Participants With Hemophilia B (PHASE3)
- Phase I/IIa Study of FIXFc in Hemophilia B Patients (PHASE1)
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:
- Factor IX (rFIXFc) CI brief — competitive landscape report
- Factor IX (rFIXFc) updates RSS · CI watch RSS
- Bioverativ Therapeutics Inc. portfolio CI