Abeona’s ZEVASKYN™ Becomes First Cell-Based Gene Therapy Approved for RDEB

Published on Spencer Knight via LinkedIn

The FDA has approved ZEVASKYN™, the first-ever autologous cell-based gene therapy for patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB). Developed by Abeona Therapeutics, this one-time gene-corrected skin graft significantly accelerates healing and reduces pain for a condition with no other approved treatments.

In clinical trials, 81% of treated wounds achieved ≥50% healing at six months, compared to just 16% with standard care. The therapy showed long-lasting effects in follow-ups up to 8 years and was well-tolerated. It also earned a Rare Pediatric Disease Priority Review Voucher, further validating its breakthrough status.

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👉 Spencer Knight: FDA Approves First Cell-Based Gene Therapy for RDEB

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