SHP 654

Drug Profile

SHP 654

Alternative Names: BAX 888; FVIII gene therapy; SHP654

Latest Information Update: 28 Oct 2017

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At a glance

  • Originator Baxalta
  • Developer Shire
  • Class Gene therapies
  • Mechanism of Action Blood coagulation factor replacements; Gene transference
  • 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

  • Preclinical Haemophilia A

Most Recent Events

  • 25 Oct 2017 SHP 654 receives Orphan Drug status for Haemophilia A in USA
  • 25 Oct 2017 US FDA approves IND application for SHP 654 in Haemophilia A
  • 25 Oct 2017 Shire plans a phase I/II trial for Haemophilia A worldwide by end of 2017
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