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Efanesoctocog alfa - Bioverativ/Sanofi

Drug Profile

Efanesoctocog alfa - Bioverativ/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: 06 May 2024

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At a glance

  • Originator Amunix
  • 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
  • Phase I Von Willebrand disease

Most Recent Events

  • 26 Apr 2024 The Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion for the Marketing Authorisation Application (MAA) of efanesoctocog alfa for the prevention and treatment of Haemophilia A
  • 06 Mar 2024 Swedish Orphan Biovitrum and Syneos Health initiates a phase IIIb FREEDOM trial for Haemophilia A (Treatment experienced, In adolescents, In adults, In elderly) in Austria, Belgium, Croatia, Czech Republic, France, Germany, Greece, Ireland, Netherlands, Norway, Slovenia, Spain, Sweden, United Kingdom (IV) (NCT05817812)
  • 31 Dec 2023 Preregistration for Haemophilia A in Saudi Arabia (IV) prior to December 2023
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