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Abeona Therapeutics Reports Encouraging Pre-BLA Discussion with FDA for EB-101 and Sets Course for BLA Submission

Thursday, August 31, 2023

Abeona Therapeutics Inc. (Nasdaq: ABEO) has revealed its plans to move forward with submitting a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for EB-101, an investigative autologous, engineered cell therapy aimed at patients with recessive dystrophic epidermolysis bullosa (RDEB). This decision follows a recent pre-BLA meeting between the company and the FDA.

During the meeting, Abeona and the FDA reached a consensus that the available clinical data on EB-101's efficacy and safety are substantial enough to support the forthcoming BLA submission. Moreover, both parties acknowledged the comparability of the retroviral vector manufactured by Abeona and Indiana University, substantiated by the data provided in Abeona's briefing book. However, the FDA did make a request for additional background information and data to be included in the BLA submission, in order to facilitate a comprehensive evaluation of EB-101's potency and identity assays post-submission.

Furthermore, the FDA requested supplementary data concerning specific aspects of chemistry, manufacturing, controls, and clinical topics to be incorporated into the BLA package. Abeona is confident in its ability to provide the necessary data to produce these supplementary reports, which encompass information about potency and identity, in order to address the FDA's queries.

Vish Seshadri, Chief Executive Officer of Abeona, expressed contentment with the outcome of the pre-BLA meeting, highlighting that their approach is in alignment with the FDA's expectations for the upcoming BLA submission. Seshadri emphasized that their immediate focus is on assembling and organizing existing data in the following weeks, with the aim of meeting the FDA's requirements. Armed with constructive input from the FDA, Abeona is now poised to follow a distinct regulatory path, leading to the projected BLA submission for EB-101 in the early months of Fall.

It is noteworthy that EB-101 has been designated by the FDA with Regenerative Medicine Advanced Therapy, Breakthrough Therapy, Orphan Drug, and Rare Pediatric Disease designations.

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