Abeona Therapeutics announces progress update on Pz-cel BLA

Abeona Therapeutics announced, as part of the review process by the U.S. Food and Drug Administration, FDA, for the Biologics License Application, BLA, for pz-cel for recessive dystrophic epidermolysis bullosa, RDEB, completion by the FDA of both a Bioresearch Monitoring, BIMO, inspection of Abeona and the BLA mid-cycle review meeting. The BIMO inspection was conducted from January 22, 2024 through January 24, 2024 at Abeona’s headquarters in Cleveland, Ohio, and reviewed the conduct and practices that pertain to the clinical studies of pz-cel. The FDA inspector did not issue any observations or FDA Form 483s during the inspection. Following the BIMO inspection, the BLA mid-cycle review meeting took place on January 25, 2024. The FDA reaffirmed its earlier indication that it does not currently plan to convene an Advisory Committee for pz-cel. In addition, the FDA advised that Risk Evaluation and Mitigation Strategies are not anticipated for the pz-cel application at this time, though application review is ongoing, and reconfirmed the PDUFA target action date of May 25, 2024, on which an approval decision on the pz-cel BLA is expected.