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# Priority Review for Abeona Therapeutics BLA
- URL: https://www.fdaweb.com/priority-review-for-abeona-therapeutics-bla/
- Published: 2023-11-27T12:00:00.000Z
- Updated: 2026-09-14T14:17:00.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5155859

FDA has accepted for priority review an Abeona Therapeutics BLA for pz-cel (prademagene zamikeracel) autologous COL7A1 gene-corrected epidermal sheets for treating patients with recessive dystrophic epidermolysis bullosa (RDEB). The agency has set a 5/25/2024 review action target date, according to the company, adding that an advisory committee meeting to discuss the submission is not currently planned.

The submission is based on data from the pivotal Phase 3 VIITAL study (NCT04227106) and confirmatory evidence from a Phase 1/2a study (NCT01263379). “Both studies revealed that a one-time application of pz-cel on large and chronic wounds delivered sustained wound healing and pain reduction,” Abeona says.

RDEB is a rare connective tissue disorder characterized by severe skin wounds that cause pain and can lead to systemic complications impacting the length and quality of life, Abeona says. “People with RDEB have a defect in the COL7A1 gene, leaving them unable to produce functioning Type VII collagen, which is necessary to anchor the dermal and epidermal layers of the skin,” it says. Pz-cel is designed to “incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells and enable long-term gene expression by using a retroviral vector to stably integrate into the dividing target cell genome,” it adds.