FDA approves Zevaskyn, the first cell-based gene therapy for wounds of recessive dystrophic epidermolysis bullosa

Abeona Therapeutics/Zevaskyn (pz-cel)

The FDA approved Zevaskyn (prademagene zamikeracel) for wounds in adults and children with recessive dystrophic epidermolysis bullosa, a genetic disease where skin tears and blisters at the slightest friction. The patient's own skin cells are modified to make working type VII collagen and grafted as sheets onto chronic wounds in a single procedure. In the VIITAL phase 3, most treated wounds healed at least halfway by six months.

• VIITAL: 81% of large chronic wounds reached ≥50% healing at 6 months vs 16% of 43 matched control wounds.
• No treatment-related serious adverse events reported across both clinical studies.
• Approved for adults and children from birth; applied once per wound area.