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: 13 Nov 2017

At a glance

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

    • 13 Nov 2017 According to a Theratechnologies media release, U.S. Food and Drug Administration (FDA) will extend its review of the Biologics License Application (BLA) for ibalizumab. The Prescription Drug User Fee Act ("PDUFA") target action date has been extended to April 3, 2018.
    • 08 Oct 2017 Results of 48-week safety and efficacy of ibalizumab presented at the IDWeek 2017
    • 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.
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