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BIVV009
BIVV009 is a monoclonal antibody that inhibits tissue factor pathway inhibitor (TFPI) to enhance thrombin generation and restore hemostasis in hemophilia patients.
BIVV009 is a monoclonal antibody that inhibits tissue factor pathway inhibitor (TFPI) to enhance thrombin generation and restore hemostasis in hemophilia patients. Used for Hemophilia A with inhibitors, Hemophilia B with inhibitors.
At a glance
| Generic name | BIVV009 |
|---|---|
| Also known as | Sutimlimab |
| Sponsor | Bioverativ, a Sanofi company |
| Drug class | TFPI inhibitor monoclonal antibody |
| Target | Tissue Factor Pathway Inhibitor (TFPI) |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
BIVV009 blocks TFPI, a natural anticoagulant that suppresses the initiation phase of coagulation. By neutralizing TFPI, the drug allows tissue factor and factor VIIa to more efficiently activate factor X, thereby bypassing the need for factors VIII or IX and restoring effective thrombin generation in hemophilia A and B patients regardless of inhibitor status.
Approved indications
- Hemophilia A with inhibitors
- Hemophilia B with inhibitors
Common side effects
- Thrombotic events
- Injection site reactions
Key clinical trials
- Sutimlimab (BIVV009) for the Adult Participants With Cold Agglutinin Disease (CAD) Who Have Completed Phase 3 Studies (CARDINAL or CADENZA) in Japan (PHASE3)
- A Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple- Dose BIVV009 in Participants With Chronic Immune Thrombocytopenia (ITP) (PHASE1)
- A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion (PHASE3)
- A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study) (PHASE3)
- Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement Mediated Disorders (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:
- BIVV009 CI brief — competitive landscape report
- BIVV009 updates RSS · CI watch RSS
- Bioverativ, a Sanofi company portfolio CI