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: 02 Aug 2018

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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.

    Yes - Haemophilia A
  • New Molecular Entity Yes

Highest Development Phases

  • Phase I/II Haemophilia A

Most Recent Events

  • 31 May 2018 Preliminary safety and pharmacokinetics data from the phase I/IIa EXTEN-A trial released by Amunix
  • 22 May 2018 Interim efficacy data from a phase I/II trial in Haemophilia released by Bioverativ
  • 10 May 2018 The United States Patent and Trademark Office (USPTO) issued a patent (No: 9 925 263) to Eagle Biologics
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