Abeona announces FDA accepts, grants priority review for pz-cel BLA

Abeona Therapeutics announced that the U.S. Food and Drug Administration, FDA, has accepted and granted Priority Review for the Biologics License Application, BLA for pz-cel, Abeona’s investigational autologous, COL7A1 gene-corrected epidermal sheets for the treatment of patients with recessive dystrophic epidermolysis bullosa. Under the Prescription Drug User Fee Act, PDUFA, the FDA has set a target action date of May 25, 2024. The FDA also advised that it does not currently plan to convene an Advisory Committee meeting to discuss the pz-cel application. “The FDA’s acceptance of our BLA for priority review underscores the high unmet need in RDEB and the potential for pz-cel to provide meaningful benefit to these patients,” said Vish Seshadri, Chief Executive Officer of Abeona. “We thank the FDA for their commitment and look forward to working with them through the BLA review, with the goal of bringing this therapy to patients as soon as possible.”