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VIITAL: A Phase 3 Study of EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)

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Trial Profile

VIITAL: A Phase 3 Study of EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Mar 2024

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At a glance

  • Drugs Prademagene zamikeracel (Primary)
  • Indications Epidermolysis bullosa dystrophica
  • Focus Registrational; Therapeutic Use
  • Acronyms VIITAL; VITAL
  • Sponsors Abeona therapeutics

    • Most Recent Events

    • 18 Mar 2024 According to an Abeona Therapeutics media release, the FDA has completed the clinical study site inspections of Stanford University School of Medicine in Palo Alto, CA and University of Massachusets Medical School in Worcester, MA, both of which enrolled subjects in the pivotal Phase 3 VIITAL™ study supporting the pz-cel BLA, with no Form 483 observations noted
    • 18 Mar 2024 According to an Abeona Therapeutics media release, Abeona received a written Establishment Inspection Report (EIR), the formal report from the FDA regarding the BIMO inspection.
    • 18 Mar 2024 According to an Abeona Therapeutics media release,FDA has completed pre-license inspection(PLI) of Abeona Cleveland manufacturing facility, as well as inspection of clinical trial sites for prademagene zamikeracel pivotal Phase 3 VIITAL study.
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