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Simoctocog alfa - Octapharma

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Drug Profile

Simoctocog alfa - Octapharma

Alternative Names: Factor VIII recombinant- Octapharma; Human-cell-line-recombinant-human-factor-VIII-Octapharma; Human-cl rhFVIII - Octapharma; Nuwiq; rFactor-VIII-Octapharma ; rFVIII-Octapharma

Latest Information Update: 18 Jan 2024

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At a glance

  • Originator Octapharma
  • Developer Cardinal Health; Emory University; Genentech; Octapharma
  • Class Antihaemorrhagics; Blood coagulation factors; Coagulants; Polyethylene glycols; Recombinant fusion proteins; Recombinant proteins
  • Mechanism of Action Blood coagulation factor replacements; Factor X stimulants
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Haemophilia A

Most Recent Events

  • 05 Jan 2024 Emory University and Genentech withdraws phase III trial for Haemophilia A (Treatment-naive, In adolescents, In adults, In children) in USA (IV) prior to enrollment due to slow enrollment and study site startup (NCT04030052)
  • 09 Dec 2023 Updated efficacy data from the phase III NuProtect trial in haemophilia presented at the 65th American Society of Hematology Annual Meeting and Exposition (ASH-Hem-2023)
  • 05 Dec 2022 Octapharma plans a phase III NuPOWER trial for Haemophilia A (Treatment-experienced) in 2023
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