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# Abeona Plans BLA for Cell Therapy
- URL: https://www.fdaweb.com/abeona-plans-bla-for-cell-therapy/
- Published: 2023-08-30T12:00:00.000Z
- Updated: 2026-09-14T18:53:34.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5155217

Abeona Therapeutics says it will file a BLA for EB-101, a cell therapy for patients with recessive dystrophic epidermolysis bullosa (RDEB), after completing a pre-BLA meeting with FDA. The meeting resulted in an “alignment” with the agency that EB-101’s clinical efficacy and safety data appear adequate to support the submission, it says. According to Abeona, they also agreed that the retroviral vector manufactured at Abeona and Indiana University appear comparable based on the data that the company provided in its briefing book.

“The FDA requested that Abeona include within its BLA submission additional background and data supporting the scientific rationale underlying its EB-101 potency and identity assays so that they can be fully evaluated by the Agency post-submission,” the company says. “The agency also requested that supplemental data pertaining to certain chemistry, manufacturing, and controls and clinical topics be included in the BLA package.” The company adds that it believes it has the necessary supporting data in-hand to respond to the additional requests.