Chemistry:Prademagene zamikeracel
| Clinical data | |
|---|---|
| Trade names | Zevaskyn |
| Other names | EB-101 |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a625079 |
| License data | |
| Routes of administration | Topical |
| ATC code |
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| Legal status | |
| Legal status | |
| Identifiers | |
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Prademagene zamikeracel, sold under the brand name Zevaskyn, is an autologous cell-based gene therapy for the treatment of recessive dystrophic epidermolysis bullosa.[1]
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
Legal status
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
- ↑ 1.0 1.1 1.2 1.3 1.4 "Zevaskyn- prademagene zamikeracel cellular sheet". 13 April 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f8782480-8782-4748-9764-b9ed60979d47.
- ↑ 2.0 2.1 2.2 2.3 "Zevaskyn". 28 April 2025. https://www.fda.gov/vaccines-blood-biologics/zevaskyn.
- ↑ 3.0 3.1 "FDA Approves Prademagene Zamikeracel, First and Only Cell-Based Gene Therapy for Recessive Dystrophic Epidermolysis Bullosa". 29 April 2025. https://www.pharmacytimes.com/view/fda-approves-prademagene-zamikeracel-first-and-only-cell-based-gene-therapy-for-recessive-dystrophic-epidermolysis-bullosa.
- ↑ "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.
- ↑ "FDA approves cell-sheet-based gene therapy for severe skin disease". Nature Reviews. Drug Discovery 24 (6): 407. June 2025. doi:10.1038/d41573-025-00082-2. PMID 40335718.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 81". WHO Drug Information 33 (1). 2019.
External links
- "Prademagene zamikeracel (Code - C175196)". https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C175196.
- Clinical trial number NCT04227106 for "Phase 3, Open-label Clinical Trial of EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)" at ClinicalTrials.gov
- Clinical trial number NCT01263379 for "Gene Transfer for Recessive Dystrophic Epidermolysis Bullosa" at ClinicalTrials.gov
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