Simoctocog alfa - Octapharma

Drug Profile

Simoctocog alfa - Octapharma

Alternative Names: Factor VIII - Octapharma; Human-cl rhFVIII - Octapharma; Nuwiq; rFactor-VIII-Octapharma ; rFVIII-Octapharma

Latest Information Update: 23 Oct 2018

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At a glance

  • Originator Octapharma
  • Developer Cardinal Health; Octapharma
  • Class Antihaemorrhagics; Blood coagulation factors; Coagulants; 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.

  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Haemophilia A

Most Recent Events

  • 09 Oct 2018 Octapharma completes a phase IIIb trial in Haemophilia A in Canada, Croatia, Finland, France, Japan, Macedonia, Netherlands, Slovenia and USA (NCT02256917) (EudraCT2014-002986-30)
  • 20 Jun 2018 EMA approves an extension of marketing authorisation for Nuwiq® single dose vial strengths 2500, 3000 and 4000 IU for treatment of Haemophilia A in Europe
  • 09 Dec 2017 Pharmacokinetics data from the preclinical studies in Haemophilia A presented at the 59th Annual Meeting and Exposition of the American Society of Hematology (ASH-2017)
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