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Prademagene zamikeracel - Abeona Therapeutics

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Drug Profile

Prademagene zamikeracel - Abeona Therapeutics

Alternative Names: EB-101; Epidermolysis bullosa gene therapy - Abeona Therapeutics; Gene-corrected skin grafts - Abeona Therapeutics; LEAES; LZRSE COL7A1; LZRSE-Col7A1 Engineered Autologous Epidermal Sheets; Pz-cel

Latest Information Update: 25 Mar 2024

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At a glance

  • Originator Abeona Therapeutics
  • Class Cell therapies; Gene therapies; Skin disorder therapies
  • Mechanism of Action Collagen type VII replacements; Gene transference
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Epidermolysis bullosa dystrophica
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Preregistration Epidermolysis bullosa dystrophica

Most Recent Events

  • 25 Mar 2024 The US FDA completes a pre-license inspection of Cleveland, Ohio manufacturing facility and issues a new Form 483
  • 27 Nov 2023 The US FDA assigns PDUFA action date of 25/05/2024 for Prademagene zamikeracel for Epidermolysis bullosa
  • 27 Nov 2023 US FDA accepts BLA for prademagene zamikeracel for Epidermolysis bullosa for review
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