ZEVASKYN Cellular sheet Ref.[115567] Active ingredients: Prademagene zamikeracel

Source: FDA, National Drug Code (US) Revision Year: 2025

Product description

ZEVASKYN is composed of autologous cells isolated from skin punch biopsies of patients with mutations in the collagen type VII alpha 1 chain (COL7A1) gene and which have been transduced ex vivo with a replication-incompetent retroviral vector (RVV) containing the full-length COL7A1 gene. The resulting gene-modified cell sheets express functional collagen VII (C7) protein. ZEVASKYN is manufactured using human- and animal-derived reagents.

ZEVASKYN is provided as cellular sheets of 41.25 cm² (5.5 cm x 7.5 cm) secured to sterile petrolatum gauze using sterile ligation titanium clips for surgical application. The cellular sheets consist of autologous, viable, gene-modified cells. Up to twelve (12) sheets may be manufactured from the patient biopsies and supplied for potential use.

Each ZEVASKYN sheet is packaged in a clamshell and sealed transport pouch containing sterile transport media. The transport media includes reagents derived from human and animal materials, including bovine pituitary extract, bovine transferrin, and human transferrin. The sheet also has a nylon suture, which functions as a visual indicator of the sheet's topography. Neither ZEVASKYN sheets nor its excipients contain preservatives.

Dosage Forms and Strengths
ZEVASKYN is supplied as single-dose cellular sheets each measuring 41.25 cm² (5.5 cm x 7.5 cm) and consisting of patient's own viable, gene-modified cells that contain functional copies of the COL7A1 gene, which express collagen 7 (C7) protein. Up to twelve (12) C7-expressing cellular sheets are supplied for each surgical session (supplied as up to 3 containers containing up to 4 sheets).

How Supplied
ZEVASKYN sheets of 41.25 cm² (5.5 cm × 7.5 cm) affixed on a rectangular gauze and placed in a clear, thermoformed protective case ("clamshell") containing sterile transport media sealed in packaging consisting of 4 levels of protection. Up to four ZEVASKYN sheets are provided in a single transport container, with up to three containers per manufactured lot, for a total of up to twelve sheets. All available sheets per manufactured lot are supplied under NDC 84103-007-01. Confirm patient identity on the drug product container upon receipt. Each sheet is supplied ready for use and is intended for application on the patient from whom the biopsy was derived for manufacturing the ZEVASKYN sheet. Due to ZEVASKYN's autologous nature, in case of a manufacturing failure, a second manufacturing of ZEVASKYN may be attempted and would require a repeat biopsy. Manufactured and Distributed by: Abeona Therapeutics Inc., 6555 Carnegie Avenue, Cleveland, OH 44103

How Supplied

ZEVASKYN sheets of 41.25 cm² (5.5 cm × 7.5 cm) affixed on a rectangular gauze and placed in a clear, thermoformed protective case ("clamshell") containing sterile transport media sealed in packaging consisting of 4 levels of protection.

Up to four ZEVASKYN sheets are provided in a single transport container, with up to three containers per manufactured lot, for a total of up to twelve sheets. All available sheets per manufactured lot are supplied under NDC 84103-007-01.

Confirm patient identity on the drug product container upon receipt.
Each sheet is supplied ready for use and is intended for application on the patient from whom the biopsy was derived for manufacturing the ZEVASKYN sheet.

Due to ZEVASKYN's autologous nature, in case of a manufacturing failure, a second manufacturing of ZEVASKYN may be attempted and would require a repeat biopsy.

Manufactured and Distributed by: Abeona Therapeutics Inc., 6555 Carnegie Avenue, Cleveland, OH 44103

Drugs

Drug	Countries
ZEVASKYN	United States

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