FDA Seeks More Information About RDEB Rx Under Review

The US Food and Drug Administration has issued a complete response letter regarding the Biologics License Application for prademagene zamikeracel , which is under review for the treatment of patients with recessive dystrophic epidermolysis bullosa , requesting more information from the manufacturer.

gene–corrected epidermal sheets, is being evaluated for its ability to enable normal type VII collagen expression in a patient's skin cells and to facilitate wound healing and pain reduction in wounds in patients with RDEB after a one-time application procedure. The cause of RDEB is a defect in thegene that"results in the inability to produce type VII collagen," a press release from the manufacturer noted.

On April 22, 2024, the manufacturer Abeona Therapeutics announced that following a meeting with the FDA in March and in a subsequent request for information, the agency requires additional information to satisfy certain Chemistry Manufacturing and Controls requirements before the BLA for pz-cel can be approved.

The CRL did not identify any issues related to the clinical efficacy or safety data in the BLA, and the FDA did not request any new clinical trials or clinical data to support approval, according to the company. The company anticipates completing the BLA resubmission in the third quarter of 2024. The application is supported by clinical efficacy and safety data from the pivotalA New York Hospital System Has a Big-Time Chef Making Big ChangesAll material on this website is protected by copyright, Copyright © 1994-2024 by WebMD LLC. This website also contains material copyrighted by 3rd parties.

Wound Care Wound Healing Wound Repair Wound Pain Pain Management Clinical Research Clinical Trials Clinical Studies Pre-Clinical Trial Double-Blind Study Double-Blind Studies Single-Blind Study Single-Blind Studies Epidermolysis Bullosa U.S. Food And Drug Administration United States Food And Drug Administration Fda Healthcare And Medical Technology

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