For Abeona Therapeutics Inc. (ABEO), the road to FDA approval for Zevaskyn was far from smooth. After facing an initial regulatory setback, the company achieved a breakthrough in April 2025, when Zevaskyn became the first and only FDA-approved cell-based gene therapy for recessive dystrophic epidermolysis bullosa.
Recessive dystrophic epidermolysis bullosa (RDEB) is caused by mutations in both copies of the COL7A1 gene that expresses Type VII collagen. The Type VII collagen is necessary to anchor the dermal and epidermal layers of the skin. People with RDEB have extremely fragile skin characterised by extensive blistering and severe wounds that often cover more than 30 percent of a patient's body surface, and in some cases up to 80 percent. RDEB wounds cause debilitating pain and systemic complications, impacting the length and quality of life. These wounds are difficult to heal, can remain open for years, and many that do close tend to reopen.
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