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Fibrinogen - Octapharma

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Drug Profile

Fibrinogen - Octapharma

Alternative Names: Factor I concentrate-Octapharma; Fibrinogen (Human) Lyophilised Powder for Reconstitution; FIBRYGA; Fibryga; Fibryna; Human fibrinogen concentrate; Octafibrin

Latest Information Update: 05 Aug 2024

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At a glance

  • Originator Octapharma
  • Developer Octapharma; University Health Network of Toronto
  • Class Acute-phase proteins; Antihaemorrhagics; Blood coagulation factors; Coagulants
  • Mechanism of Action Fibrinogen replacements
  • 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 Afibrinogenaemia

Most Recent Events

  • 01 Aug 2024 US FDA grants expanded approval for Fibrinogen for Afibrinogenaemia
  • 29 Mar 2021 Registered for Afibrinogenaemia (on-demand treatment of acute bleeding episodes) (In neonates, In infants) in USA (IV)
  • 05 Dec 2020 Pooled efficacy and adverse events data from a phase III FORMA-02 and FORMA-04 trial in Congenital Fibrinogen Deficiency presented at the 62nd Annual Meeting and Exposition of the American Society of Hematology (ASH-Hem-2020)

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