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Eptacog alfa - Novo Nordisk

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Drug Profile

Eptacog alfa - Novo Nordisk

Alternative Names: Activated recombinant human factor VII; Factor VIIa; NiaStase; NN 007; NovoSeven; NovoSeven RT; NovoSeven RT with MixProT; NovoSeven with pre-filled syringe; Novostase; Recombinant factor VIIa; rFVIIa

Latest Information Update: 05 Nov 2023

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At a glance

  • Originator ZymoGenetics
  • Developer Novo Nordisk
  • Class Antihaemorrhagics; Blood coagulation factors; Recombinant proteins
  • Mechanism of Action Factor VIIa stimulants; Factor X stimulants
  • Orphan Drug Status

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

    Yes - Haemophilia; Thrombasthenia; Haemorrhage
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Factor VII deficiency; Haemophilia; Thrombasthenia
  • Registered Postpartum haemorrhage
  • Phase III Haemorrhage

Most Recent Events

  • 21 Feb 2023 Registered for Postoperative haemorrhage in European Union (IV) , prior to February 2023
  • 22 Apr 2022 The EMA's Committee for Medicinal Products for Human Use recommended approval of eptacog alfa for severe postpartum haemorrhage in European Union
  • 22 Apr 2022 Interim efficacy and adverse events data from a clinical trial in postoperative haemorrhage released by Novo Nordisk

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