Abeona Therapeutics Resubmits Application for Promising RDEB Treatment Pz-cel
Abeona Therapeutics announced today that it has resubmitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Pz-cel (prademagene zamikeracel), an investigational treatment for Recessive Dystrophic Epidermolysis Bullosa (RDEB). This innovative therapy, which utilizes gene-corrected epidermal sheets, aims to help wounds heal and reduce pain for those living with this challenging condition.
This marks Abeona's second submission of the BLA for Pz-cel. In April 2024, the FDA requested additional information on the manufacturing and testing processes used in Pz-cel’s production as part of their Chemistry Manufacturing and Controls (CMC) requirements. Importantly, the FDA raised no concerns about the clinical safety or efficacy of Pz-cel, nor did it ask for additional trials or clinical data, a positive sign for Abeona’s continued progress.
Pz-cel has demonstrated promising results in their Phase 3 VIITAL™ and Phase 1/2a trials, showing that the application of Pz-cel once on large and chronic wounds helped them heal and reduced pain.
“We have worked closely with the FDA in preparing for the pz-cel BLA resubmission and thank the Agency for their ongoing guidance”, Vish Seshadri, Chief Executive Officer of Abeona, stated in a press release. “We have incorporated the Agency’s feedback and are confident that our resubmission package addresses all the Chemistry Manufacturing and Controls items identified in the Complete Response Letter…”
If accepted, the FDA will set a new Prescription Drug User Fee Act (PDUFA) target action date, which determines the expected timeline for the FDA’s review. The review period for a resubmitted BLA can range from two to six months, depending on the classification assigned by the FDA. Typically, a decision on whether the BLA will proceed is made within 14 days of resubmission.
This resubmission represents an important step toward another potential treatment for EB! Stay tuned.
