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Efanesoctocog alfa - Sanofi

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Drug Profile

Efanesoctocog alfa - Sanofi

Alternative Names: ALTUVIIIO; Altuviiio; Altuvoct; Antihemophilic factor (recombinant) - Bioverativ/Sanofi; BIVV-001; Factor VIII recombinant - Bioverativ/Sanofi; Fc-VWF-XTEN fusion protein-ehtl; Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion protein; rFVIIIFc-VWF-XTEN; rFVIIIFc-XTEN-vWF; XTENylated Factor VIII

Latest Information Update: 21 Apr 2025

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At a glance

  • Originator Amunix; Bioverativ
  • Developer Amunix; Bioverativ; Sanofi; Swedish Orphan Biovitrum
  • Class Antihaemorrhagics; Blood coagulation factors; Recombinant fusion proteins
  • Mechanism of Action Factor VIII replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Haemophilia A
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Haemophilia A
  • Discontinued Von Willebrand disease

Most Recent Events

  • 06 Mar 2025 Swedish Orphan Biovitrum initiates a phase III LIBERTY trial for Severe Haemophilia A (Treatment-experienced, In children, In adolescents, In adults, In the elderly) in Italy and Spain (NCT06716814)
  • 15 Jan 2025 Phase-I clinical trials in Haemophilia A (Treatment-experienced) in Spain, Italy, Germany (IV) (NCT06579144)
  • 07 Dec 2024 Interim efficacy and adverse events data from a phase III XTEND-ed Long-Term Extension trial in Haemophilia A presented at the 66th American Society of Hematology Annual Meeting and Exposition (ASH-Hem-2024)

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