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BAX855
BAX855 is a recombinant factor VIII (antihemophilic factor) fused to the Fc portion of human immunoglobulin G1 to extend half-life and improve hemostasis in hemophilia A.
BAX855 is a recombinant factor VIII (antihemophilic factor) fused to the Fc portion of human immunoglobulin G1 to extend half-life and improve hemostasis in hemophilia A. Used for Hemophilia A (on-demand and prophylactic treatment).
At a glance
| Generic name | BAX855 |
|---|---|
| Also known as | ADYNOVATE, BAX 855, PEGylated Recombinant Factor VIII |
| Sponsor | Baxalta now part of Shire |
| Drug class | Recombinant factor VIII (Fc fusion protein) |
| Target | Factor VIII / Intrinsic tenase complex |
| Modality | Biologic |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
BAX855 replaces deficient or dysfunctional factor VIII, a critical clotting factor, allowing patients with hemophilia A to form stable blood clots. The Fc fusion extends the drug's circulating half-life compared to conventional factor VIII products, potentially reducing dosing frequency. This enables better sustained factor VIII activity and improved hemostatic control.
Approved indications
- Hemophilia A (on-demand and prophylactic treatment)
Common side effects
- Inhibitor development (factor VIII antibodies)
- Injection site reactions
- Headache
- Hypersensitivity reactions
Key clinical trials
- A Long-term Study of ADYNOVI/ADYNOVATE in Participants With Haemophilia A
- Pharmacokinetic Assessment of Standard Half-Life (SHL) FVIII, Extended Half-Life (EHL) FVIII, and Efanesoctocog Alfa (BIVV001) in Severe Hemophilia A (PHASE1)
- A Study of PEGylated Recombinant Factor VIII (BAX855) in Previously Untreated Young Children With Severe Hemophilia A (PHASE3)
- A Study of Adynovate in Previously Treated Chinese Teenagers and Adults With Severe Hemophilia A (PHASE3)
- POCUS: Hemostatic Potential and Joint Health in Patients With Severe Hemophilia A on Novel Replacement Therapies (PHASE4)
- ADYNOVATE Drug Use-Results Survey
- A Study of TAK-660 in Surgical Procedures for People With Hemophilia A.
- ADVATE/ ADYNOVI Hemophilia A Outcome Database (AHEAD)
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 |