Abeona Therapeutics announces FDA completed PLI of its Ohio facility

Abeona announced that the U.S. Food and Drug Administration, FDA , has completed a Pre-License Inspection, PLI, of its Cleveland, Ohio manufacturing facility related to the Company’s Biologics License Application, BLA, for pz-cel for recessive dystrophic epidermolysis bullosa. During the inspection, the FDA reviewed the facilities, systems, and processes at the Cleveland site. The FDA also observed the manufacturing process for pz-cel, as well as performance of in-process and release assays. The two-week PLI, which was conducted by five FDA inspectors, concluded on March 1, 2024. Upon completion of the inspection, a Form 483 was issued with observations related to process controls. On March 15, 2024, the Company submitted a response to the FDA, outlining already implemented and ongoing steps toward resolution that follow FDA guidance provided during the audit. In addition, the FDA has completed the clinical study site inspections of Stanford University School of Medicine in Palo Alto, CA and University of Massachusets Medical School in Worcester, MA, both of which enrolled subjects in the pivotal Phase 3 VIITAL study supporting the pz-cel BLA, with no Form 483 observations noted.