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Efanesoctocog Alfa BIVV001
Efanesoctocog alfa (BIVV001) is a bispecific antibody that bridges Factor IX and Factor X to restore the intrinsic tenase complex activity in hemophilia A patients lacking functional Factor VIII.
Efanesoctocog alfa (BIVV001) is a bispecific antibody that bridges Factor IX and Factor X to restore the intrinsic tenase complex activity in hemophilia A patients lacking functional Factor VIII. Used for Hemophilia A (with or without Factor VIII inhibitors).
At a glance
| Generic name | Efanesoctocog Alfa BIVV001 |
|---|---|
| Also known as | ALTUVIIIO |
| Sponsor | Sanofi |
| Drug class | Bispecific antibody; Factor VIII bypass agent |
| Target | Factor IX and Factor X |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
BIVV001 is engineered to simultaneously bind Factor IX and Factor X, effectively bypassing the need for Factor VIII by reconstituting the tenase complex that generates Factor Xa. This allows patients with hemophilia A to generate thrombin through an alternative pathway, restoring hemostatic capacity without requiring exogenous Factor VIII replacement therapy.
Approved indications
- Hemophilia A (with or without Factor VIII inhibitors)
Common side effects
- Thrombotic events
- Injection site reactions
- Headache
Key clinical trials
- 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)
- Efanesoctocog Alfa Prophylaxis in Patients With Hemophilia A With Synovial Hypertrophy (PHASE4)
- A Study Evaluating Physical Activity and Joint Health in Severe Haemophilia A Patients ≥12 Years Treated Once Weekly With Efanesoctocog Alfa (PHASE3)
- A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A in Taiwan
- A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A
- To Assess the Pharmacokinetics and Safety and Tolerability of Efanesoctocog Alfa (BIVV001)in Adults With Type 2N and 3 Von Willebrand Disease (VWD) (PHASE1)
- Pharmacokinetic Assessment of Standard Half-Life (SHL) FVIII, Extended Half-Life (EHL) FVIII, and Efanesoctocog Alfa (BIVV001) in Severe Hemophilia A (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:
- Efanesoctocog Alfa BIVV001 CI brief — competitive landscape report
- Efanesoctocog Alfa BIVV001 updates RSS · CI watch RSS
- Sanofi portfolio CI