BIVV 001

Drug Profile

BIVV 001

Alternative Names: BIVV-001; Factor VIII recombinant - Amunix/Bioverativ; rFVIIIFc-VWF-XTEN; rFVIIIFc-XTEN-vWF; XTENylated Factor VIII

Latest Information Update: 10 Sep 2017

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At a glance

  • Originator Amunix
  • Developer Amunix; Bioverativ
  • Class Blood coagulation factors; Recombinant fusion 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.

  • New Molecular Entity Yes

Highest Development Phases

  • Phase I/II Haemophilia A

Most Recent Events

  • 02 Aug 2017 Phase-I/II clinical trials in Haemophilia A in USA (IV) (NCT03205163)
  • 12 Jun 2017 US FDA accepts IND for BIVV 001 for Haemophilia A for review
  • 01 Feb 2017 Biogen has separated its Haemophilia Business under a new company Bioverativ
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