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A Phase 3 Study of the Safety of Trogarzo Administered as an Undiluted "IV Push" Over a Reduced Interval in Clinically Stable HIV-1 Infected Trogarzo Experienced Patients

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Trial Profile

A Phase 3 Study of the Safety of Trogarzo Administered as an Undiluted "IV Push" Over a Reduced Interval in Clinically Stable HIV-1 Infected Trogarzo Experienced Patients

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Apr 2024

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At a glance

  • Drugs Ibalizumab (Primary) ; Ibalizumab (Primary) ; Ibalizumab
  • Indications HIV-1 infections
  • Focus Adverse reactions; Pharmacokinetics; Registrational
  • Sponsors TaiMed Biologics

    • Most Recent Events

    • 06 Mar 2024 Results assessing the safety and efficacy of IV and IM administration of Ibalizumab for the treatment of HIV-1 infection in heavily treatment experienced (HTE) people with HIV, presented at the 31st Conference on Retroviruses and Opportunistic Infections 2024
    • 28 Feb 2024 According to a Theratechnologies media release, the FDA has issued a refusal to file letter (RTF) to a supplemental Biologics License Application (sBLA) filed by Theratechnologies Inc. for an intramuscular (IM) method of administration for maintenance dosing of Trogarzo (ibalizumab-uiyk). The RTF followed a preliminary review of sBLA by FDA, which found that application did not include data agency required to establish a pharmacokinetic bridge between IM and IV administration.
    • 02 Jan 2024 According to a Theratechnologies media release, the Company has filed a supplemental Biologics License Application (sBLA) for an IM method of administration for the maintenance dose of Trogarzo to the United States Food and Drug Administration (FDA) for review. In accordance with the FDAs filing review period, Theratechnologies expects to receive an acknowledgment letter of the sBLA application within 30 days along with a PDUFA goal date
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