Last reviewed · How we verify
PEGylated Recombinant Factor VIII
PEGylated Recombinant Factor VIII is a recombinant form of human factor VIII that is modified with polyethylene glycol (PEG) to prolong its half-life.
PEGylated Recombinant Factor VIII is a recombinant form of human factor VIII that is modified with polyethylene glycol (PEG) to prolong its half-life. Used for Hemophilia A, for the prevention and control of bleeding episodes, Surgery in patients with hemophilia A.
At a glance
| Generic name | PEGylated Recombinant Factor VIII |
|---|---|
| Also known as | BAX 855, TAK-660, BAX855, ADYNOVATE |
| Sponsor | Baxalta now part of Shire |
| Drug class | Factor VIII replacement therapy |
| Target | Factor VIII |
| Modality | Biologic |
| Therapeutic area | Hemophilia A |
| Phase | Phase 3 |
Mechanism of action
This modification allows for less frequent dosing and improved stability of the protein. PEGylation also reduces the immunogenicity of the protein, which can lead to fewer side effects and improved efficacy.
Approved indications
- Hemophilia A, for the prevention and control of bleeding episodes
- Surgery in patients with hemophilia A
Common side effects
- Headache
- Nausea
- Fatigue
Key clinical trials
- A Long-term Study of ADYNOVI/ADYNOVATE in Participants With Haemophilia A
- 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)
- Phase 3 Clinical Project of Pegylated Recombinant Human Coagulation Factor VIII-Fc Fusion Protein (PHASE3)
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:
- PEGylated Recombinant Factor VIII CI brief — competitive landscape report
- PEGylated Recombinant Factor VIII updates RSS · CI watch RSS
- Baxalta now part of Shire portfolio CI