Rurioctocog alfa pegol - Shire

Drug Profile

Rurioctocog alfa pegol - Shire

Alternative Names: Adynovate; Adynovi; Antihemophilic Factor (Recombinant), PEGylated - Shire; BAX-855; EHL rFVIII PEG; Extended half-life recombinant FVIII; Full-length longer-acting rFVIII; LA rFVIII PEG; PEG factor VIII - Shire; PEGylated recombinant factor VIII; PEGylated rFVIII; SHP660

Latest Information Update: 16 Jan 2018

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At a glance

  • Originator Baxter International; Nektar Therapeutics
  • Developer Shire
  • Class Antihaemorrhagics; Blood coagulation factors; Polyethylene glycols; Recombinant proteins
  • Mechanism of Action Blood coagulation factor 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 No

Highest Development Phases

  • Marketed Haemophilia A

Most Recent Events

  • 15 Jan 2018 Registered for Haemophilia A (In adolescents, In adults, Treatment-experienced) in European Union, Iceland, Norway and Liechtenstein (IV)
  • 09 Nov 2017 The Committee for Medicinal Products for Human Use recommends approval of Rurioctocog alfa for Haemophilia A (In adolescents, Treatment-experienced, In adults) in European Union (IV)
  • 22 Mar 2017 Launched for Haemophilia A (In adolescents, In children, Treatment-experienced, In adults) in Australia (IV) after March 2017
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