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A Phase 1/2A Single Center Trial of Gene Transfer for Recessive Dystrophic Epidermolysis Bullosa (RDEB) Using the Drug LZRSE-Col7A1 Engineered Autologous Epidermal Sheets (LEAES)

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A Phase 1/2A Single Center Trial of Gene Transfer for Recessive Dystrophic Epidermolysis Bullosa (RDEB) Using the Drug LZRSE-Col7A1 Engineered Autologous Epidermal Sheets (LEAES)

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 21 Nov 2024

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At a glance

  • Drugs Prademagene zamikeracel (Primary)
  • Indications Epidermolysis bullosa dystrophica
  • Focus Proof of concept; Registrational; Therapeutic Use
  • Sponsors Abeona therapeutics

    • Most Recent Events

    • 12 Nov 2024 According to an Abeona Therapeutics media release, the company announced that the U.S. Food and Drug Administration (FDA) has accepted for review Abeona's resubmission of its Biologics License Application (BLA) for prademagene zamikeracel (pz-cel). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of April 29, 2025.
    • 29 Oct 2024 According to an Abeona Therapeutics media release, the Company has resubmitted its Biologics License Application (BLA) to the USFDA for prademagene zamikeracel (pz-cel). Upon the acceptance of BLA, the company looks forward to assist FDA in the completion of its review, and expects a new Prescription Drug User Fee Act (PDUFA) target action date from USFDA. The BLA resubmission is supported by clinical efficacy and safety data from the pivotal Phase 3 VIITAL study and this study.
    • 12 Aug 2024 According to an Abeona Therapeutics media release, On August 8, 2024, company completed a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss Abeona's forthcoming resubmission of its Biologics License Application (BLA) for prademagene zamikeracel in development for recessive dystrophic epidermolysis bullosa.

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