A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura

Trial Profile

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura

Completed
Phase of Trial: Phase III

Latest Information Update: 04 Oct 2017

At a glance

  • Drugs Fostamatinib (Primary)
  • Indications Immune thrombocytopenic purpura
  • Focus Registrational; Therapeutic Use
  • Acronyms FIT
  • Sponsors Rigel Pharmaceuticals
  • Most Recent Events

    • 22 Jun 2017 According to a Rigel Pharmaceuticals media release, data will be presented at the European Hematology Association 22nd Annual Congress (EHA).
    • 19 Jun 2017 According to a Rigel Pharmaceuticals media release, based on the data from the Phase 3 clinical program [Study 047, 048 and 049] the U.S. FDA has accepted New Drug Application for the use of TAVALISSE (fostamatinib disodium) in patients with chronic or persistent immune thrombocytopenia. Together with an initial proof of concept study, the NDA included 163 ITP patients. The company expects the action date for the FDA to complete its review will be April 17, 2018, under the PDUFA.
    • 17 Apr 2017 According to a Rigel Pharmaceuticals media release, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for fostamatinib in patients with chronic and persistent immune thrombocytopenia (ITP), NDA is supported by data from the Phase 3 clinical program [Study 047, 048 and 049]
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