US FDA approves Zevaskyn (prademagene zamikeracel), the first and only cell-based gene therapy for patients with recessive dystrophic epidermolysis bullosa

Abeona Therapeutics

29 April 2025 - Rare paediatric disease priority review voucher granted by FDA.

Abeona Therapeutics today announced the US FDA has approved Zevaskyn (prademagene zamikeracel) gene-modified cellular sheets, also known as pz-cel, as the first and only autologous cell-based gene therapy for the treatment of wounds in adult and paediatric patients with recessive dystrophic epidermolysis bullosa, a serious and debilitating genetic skin disease.

Read Abeona Therapeutics press release

Michael Wonder

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Michael Wonder

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Outcome , US , Registration , Gene therapy