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Moroctocog alfa (AF-CC)
Moroctocog alfa is a recombinant human coagulation factor VIII that replaces deficient or dysfunctional factor VIII to restore blood clotting ability in hemophilia A patients.
Moroctocog alfa is a recombinant human coagulation factor VIII that replaces deficient or dysfunctional factor VIII to restore blood clotting ability in hemophilia A patients. Used for Hemophilia A (congenital factor VIII deficiency) — treatment and prophylaxis of bleeding episodes.
At a glance
| Generic name | Moroctocog alfa (AF-CC) |
|---|---|
| Also known as | Xyntha, ReFacto AF |
| Sponsor | Pfizer |
| Drug class | Recombinant coagulation factor VIII |
| Target | Coagulation factor VIII |
| Modality | Biologic |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
Mechanism of action
Factor VIII is a critical cofactor in the intrinsic coagulation cascade that works with von Willebrand factor to activate factor X, ultimately leading to thrombin generation and fibrin clot formation. Moroctocog alfa (AF-CC) is a B-domain deleted recombinant factor VIII with an added albumin fusion domain to extend half-life. By providing functional factor VIII, it corrects the coagulation defect in hemophilia A, enabling normal hemostasis and reducing bleeding episodes.
Approved indications
- Hemophilia A (congenital factor VIII deficiency) for treatment and prevention of bleeding episodes
Common side effects
- Inhibitor development (factor VIII antibodies)
- Injection site reactions
- Headache
- Hypersensitivity reactions
Key clinical trials
- Moroctocog Alfa (AF-CC) for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Hemophilia A Patients (PHASE4)
- Study Evaluating Prophylaxis Treatment & Characterizing Efficacy, Safety, & PK Of B-Domain Deleted Recombinant FVIII (PHASE3)
- PF-05208756, Moroctocog Alfa (AF-CC), Xyntha For Hemophilia A (PHASE4)
- Study Evaluating Safety And Efficacy Of Moroctocog Alfa (AF-CC) In Previously Treated Hemophilia A Patients (PHASE4)
- Study of PF-05208756, Moroctocog Alfa (AF-CC), Xyntha For Male Chinese Subjects With Hemophilia A (PHASE1)
- Study Evaluating Safety Of Patients Switching To ReFacto AF In Usual Care Settings (PHASE4)
- Relative Bioavailability Of Two Formulations Of Moroctocog Alfa (AF-CC) (PHASE1)
- Study Evaluating The Safety Of Xyntha In Usual Care Settings (PHASE4)
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:
- Moroctocog alfa (AF-CC) CI brief — competitive landscape report
- Moroctocog alfa (AF-CC) updates RSS · CI watch RSS
- Pfizer portfolio CI