CLEVELAND - Abeona Therapeutics Inc. (NASDAQ:ABEO), a clinical-stage biopharmaceutical company, recently underwent a U.S. Food and Drug Administration (FDA) Bioresearch Monitoring (BIMO) inspection with no observations or FDA Form 483s issued, as part of the ongoing review for its Biologics License Application (BLA) for pz-cel (prademagene zamikeracel). The product is being developed to treat recessive dystrophic epidermolysis bullosa (RDEB), a rare genetic disorder.
The BIMO inspection, which took place from January 22 through January 24 at Abeona's headquarters, assessed the clinical study conduct for pz-cel. This inspection is part of the FDA's broader efforts to ensure the integrity of data submitted for new product approvals. A formal report from the FDA regarding the inspection will be provided at a later date.
Following the inspection, on January 25, the FDA conducted a mid-cycle review meeting for the BLA of pz-cel. During the meeting, the FDA indicated that it does not currently plan to convene an Advisory Committee for the review of pz-cel and does not anticipate the need for Risk Evaluation and Mitigation Strategies (REMS) at this time. The FDA also reconfirmed the Prescription Drug User Fee Act (PDUFA) target action date of May 25, 2024, when a decision on the approval of pz-cel is expected.
Abeona's CEO, Vish Seshadri, expressed the company's commitment to working with the FDA to expedite the review of pz-cel, aiming to bring this potential therapy to patients as soon as possible.
Abeona specializes in the development of cell and gene therapies for serious diseases. The company's manufacturing facility, which produced pz-cel used in its Phase 3 VIITAL™ trial, is prepared to support commercial production upon FDA approval. In addition to pz-cel, Abeona's portfolio includes AAV-based gene therapies for ophthalmic diseases and research into next-generation AAV capsids to enhance delivery for various diseases.
This article is based on a press release statement from Abeona Therapeutics Inc. and contains no endorsements or speculative content.
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