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Abeona Therapeutics Announces FDA Accepts and Grants Priority Review for Pz-cel Biologics License Application (BLA)
- PDUFA target action date is May 25, 2024 - - FDA does not currently plan to hold Advisory Committee meeting for pz-cel BLA - CLEVELAND, Nov. 27, 2023 (GLOBE
About this update from Abeona Therapeutics Inc.
[{"type":"text","content":"- PDUFA target action date is May 25, 2024 - - FDA does not currently plan to hold Advisory Committee meeting for pz-cel BLA - CLEVELAND, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today 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 (prademagene zamikeracel), Abeona’s investigational autologous, COL7A1 gene-corrected epidermal sheets for the treatment of patients with recessive dystrophic epidermolysis bullosa (RDEB). 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.” The BLA is supported by clinical efficacy and safety data from the pivotal Phase 3 VIITAL™ study (NCT04227106) and confirmatory evidence from a Phase 1/2a study (NCT01263379). Both studies revealed that a one-time application of pz-cel on large and chronic wounds delivered sustained wound healing and pain reduction. Data from the VIITAL™ study were presented during the inaugural International Societies for Investigative Dermatology (ISID) Meeting in May 2023. Long-term follow up data up to eight years and quality of life data from the Phase 1/2a study were published in Orphanet Journal of Rare Diseases. The grant of the Priority Review status is an important prerequisite for Abeona’s eligibility for a Priority Review Voucher. About Recessive Dystrophic Epidermolysis Bullosa Recessive dystrophic epidermolysis bullosa (RDEB), a rare connective tissue disorder, is characterized by severe skin wounds that cause pain and can lead to systemic complications impacting the length and quality of life. People with RDEB have a defect in the COL7A1 gene, leaving them unable to produce functioning Type VII collagen, which is necessary to anchor the dermal and epidermal ...