Prademagene zamikeracel

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Prademagene zamikeracel
Clinical data
Trade names Zevaskyn
Other namesEB-101
AHFS/Drugs.com Monograph
MedlinePlus a625079
License data
Routes of
administration 		Topical
ATC code
  • None
Legal status
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UNII

Prademagene zamikeracel, sold under the brand name Zevaskyn, is an autologous cell-based gene therapy for the treatment of recessive dystrophic epidermolysis bullosa. [1]

Contents

Prademagene zamikeracel is a cell sheet-based gene therapy for the treatment of wounds in people with recessive dystrophic epidermolysis bullosa, a rare and debilitating genetic skin disorder caused by mutations in the COL7A1 gene. [3] The therapy utilizes the recipient's own skin cells, genetically engineered to express functional type VII collagen, which are expanded into sheets and surgically applied to chronic wounds. [3]

Prademagene zamikeracel was approved for medical use in the United States in April 2025. [1] [2]

Medical uses

Prademagene zamikeracel is indicated for the treatment of wounds in people with recessive dystrophic epidermolysis bullosa. [1]

Society and culture

Prademagene zamikeracel was approved for medical use in the United States in April 2025. [2] [4] [5]

Names

Prademagene zamikeracel is the international nonproprietary name. [6]

Prademagene zamikeracel is sold under the brand name Zevaskyn. [1] [2]

References

  1. 1 2 3 4 5 "Zevaskyn- prademagene zamikeracel cellular sheet". DailyMed. 13 April 2025. Retrieved 7 July 2025.
  2. 1 2 3 4 "Zevaskyn". U.S. Food and Drug Administration (FDA). 28 April 2025. Retrieved 7 July 2025.
  3. 1 2 Antrim A (29 April 2025). "FDA Approves Prademagene Zamikeracel, First and Only Cell-Based Gene Therapy for Recessive Dystrophic Epidermolysis Bullosa". Pharmacy Times. Retrieved 29 April 2025.
  4. ↑ "U.S. FDA Approves Zevaskyn (prademagene zamikeracel), the First and Only Cell-Based Gene Therapy for Patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB)" (Press release). Abeona Therapeutics. 29 April 2025. Retrieved 7 July 2025– via GlobeNewswire.
  5. ↑ Mullard A (June 2025). "FDA approves cell-sheet-based gene therapy for severe skin disease". Nature Reviews. Drug Discovery. 24 (6): 407. doi:10.1038/d41573-025-00082-2. PMID   40335718.
  6. ↑ World Health Organization (2019). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 81". WHO Drug Information. 33 (1). hdl: 10665/330896 .
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