FDA Approves Zevaskyn Gene Therapy for RDEB

The FDA has approved Zevaskyn (prademagene zamikeracel), developed by Abeona Therapeutics, as the first autologous cell-based gene therapy for treating wounds in adults and children with recessive dystrophic epidermolysis bullosa (RDEB). Zevaskyn is made from a patient's own genetically modified skin cells and is surgically applied as sheets to large, unhealed wounds to restore functional type VII collagen. In pivotal phase III trials, a single application led to significant wound healing, with over 80% of treated wounds achieving at least 50% healing at six months, compared to 16% with standard care, and also resulted in notable pain reduction. The therapy was well-tolerated, with procedural pain and itch reported in fewer than 5% of patients. Zevaskyn addresses a major unmet need for RDEB patients by providing substantial wound healing and pain relief with just one application. It is expected to become available in the third quarter of 2025 at specialized treatment centers.