Abeona Therapeutics Submits Briefing Package for Pre-BLA Meeting with FDA in August 2023

EB-101 is an investigational autologous, engineered cell therapy currently in development for recessive dystrophic epidermolysis bullosa.

Abeona Therapeutics Inc. completed the submission of the briefing package to the U.S. Food and Drug Administration (FDA) for the Company’s pre-Biologics License Application (BLA) meeting in August 2023. 

The purpose of the meeting is to discuss the format, content, and acceptability of the anticipated BLA for EB-101, Abeona’s investigational autologous, engineered cell therapy for recessive dystrophic epidermolysis bullosa.

“In response to the FDA’s request, we have generated additional data to establish comparability between retroviral vectors from two different sources that were used in the EB-101 clinical studies, and have included this data in the briefing package for our pre-BLA meeting with the FDA in August of 2023,” says Vish Seshadri, Chief Executive Officer of Abeona, in a news release.  “We look forward to discussing various clinical and chemistry, manufacturing, and controls aspects of our data package at the pre-BLA meeting, and anticipate submitting the EB-101 BLA in the third quarter of 2023.”