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Synonyms: ALTUVIIIO® | Altuvoct® | BIVV-001 | BIVV001 | Fc-VWF-XTEN
efanesoctocog alfa is an approved drug (FDA (2023), EMA (2024))
Compound class:
Peptide
Comment: Efanesoctocog alfa (BIVV-001) is a recombinant protein that fuses factor VIII (FVIII) to a human IgG1 Fc domain. It was designed as a long-acting FVIII replacement therapy [4]. Pharmacodynamic effects of efanesoctocog alfa (clot formation) are identical to those elicited by recombinant FVIII [1].
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Summary of Clinical Use  |
| Efanesoctocog alfa was first approved by the FDA in February 2023 [2], as a once-weekly infusion for individuals with congenital FVIII deficiency (haemophilia A). It is also a clinical candidate for the treatment of Von Willebrand's disease (VWD). |
| Clinical Trials | |||||
| Clinical Trial ID | Title | Type | Source | Comment | References |
| NCT05817812 | A Study Evaluating Physical Activity and Joint Health in Severe Haemophilia A Patients ≥12 Years Treated Once Weekly With Efanesoctocog Alfa | Phase 3 Interventional | Swedish Orphan Biovitrum | ||
| NCT04644575 | Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A | Phase 3 Interventional | Sanofi | ||
| NCT04161495 | A Phase 3 Open-label Interventional Study of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, Efanesoctocog Alfa (BIVV001), in Patients With Severe Hemophilia A | Phase 3 Interventional | Sanofi | 5 | |
