A Phase 3, Single Arm, 24-Week, Multicenter Study of Ibalizumab Plus an Optimized Background Regimen (OBR) in Treatment-Experienced Patients Infected With Multi-Drug Resistant HIV-1

Trial Profile

A Phase 3, Single Arm, 24-Week, Multicenter Study of Ibalizumab Plus an Optimized Background Regimen (OBR) in Treatment-Experienced Patients Infected With Multi-Drug Resistant HIV-1

Completed
Phase of Trial: Phase III

Latest Information Update: 30 Jun 2017

At a glance

  • Drugs Ibalizumab (Primary)
  • Indications HIV-1 infections
  • Focus Therapeutic Use
  • Sponsors TaiMed Biologics
  • Most Recent Events

    • 30 Jun 2017 U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for ibalizumab as a treatment for multidrug resistant Human Immunodeficiency Virus-1 (MDR HIV-1), and set a Prescription Drug User Fee Act (PDUFA) target action date of January 3, 2018.
    • 10 Jun 2017 Biomarkers information updated
    • 03 May 2017 According to a Theratechnologies media release, based on the data from this trial, TaiMed Biologics, Inc., has completed the submission of a Biologics License Application (BLA) to the U.S. FDA for ibalizumab for the treatment of multidrug resistant Human Immunodeficiency Virus-1 (MDR HIV-1). The company has requested Priority Review for the application.
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