Brand Name
Zevaskyn
Generic Name
Prademagene Zamikeracel
View Brand Information FDA approval date: April 13, 2025
Form: Cellular
What is Zevaskyn (Prademagene Zamikeracel)?
ZEVASKYN is indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa . ZEVASKYN is an autologous cell sheet-based gene therapy indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa .
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Brand Information
ZEVASKYN (prademagene zamikeracel)
1INDICATIONS AND USAGE
ZEVASKYN is indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).
2DOSAGE FORMS AND STRENGTHS
ZEVASKYN is supplied as single-dose cellular sheets each measuring 41.25 cm
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).
3CONTRAINDICATIONS
None.
4DESCRIPTION
ZEVASKYN is composed of autologous cells isolated from skin punch biopsies of patients with mutations in the
ZEVASKYN is provided as cellular sheets of 41.25 cm
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.
5CLINICAL STUDIES
The efficacy of ZEVASKYN was evaluated in a multi-center, randomized, intrapatient-controlled study (VIITAL; NCT04227106). The study compared the application of ZEVASKYN to the standard of care treatment in patients with wounds associated with recessive dystrophic epidermolysis bullosa (RDEB). For enrollment, the patients were required to have at least one pair of matched, large (at least one wound ≥20 cm
A total of 86 wounds in 11 patients were enrolled and treated with ZEVASKYN or standard of care in the study. The demographic characteristics of the population were as follows: the mean age was 23 years (range 6 to 40 years) including 2 pediatric patients (aged 6 and 16 years), 7 patients (64%) were female, 10 patients (91%) were White, 1 patient (9%) was of unknown race, and 2 patients (18%) were Hispanic or Latino. The wounds assessed in the study at baseline had been open for a median of 5 years (range 0.5-21 years).
The co-primary efficacy outcome measures were 1) proportion of randomized wound pairs with at least 50% healing at Month 6 with confirmation of wound healing two weeks later as assessed using baseline digital photography by the Investigator, and 2) pain reduction as assessed by the mean differences in patient-reported pain scores using the Wong-Baker FACES scale between randomized wound pairs at Month 6.
The efficacy results are summarized in Table 2.
N=total number of observations; SD=Standard deviation; %=percentage
Complete wound healing is defined as re-epithelialization with no drainage or erosion and presence of only minor crusting.
a The proportion of wounds achieving success criteria at Month 6 must have been confirmed at least 2 weeks later.
b One wound was excluded from the control group due to missing baseline value.
6REFERENCES
- Wong-Baker FACES Foundation. Wong-Baker FACES Pain Rating Scale. Retrieved 24 July 2023 with permission from http://www.WongBakerFACES.org. Originally published in Whaley & Wong’s Nursing Care of Infants and Children. Elsevier Inc. 2022.
7PATIENT COUNSELING INFORMATION
Discuss the following with patients and/or caregivers.
- Hypersensitivity Reactions: Inform patients and/or caregivers that hypersensitivity reactions may occur with ZEVASKYN application. Advise patients and/or caregivers to seek immediate medical evaluation if any signs and symptoms of hypersensitivity reaction occur, such as itching, swelling, hives, difficulty breathing, runny nose, watery eyes, nausea, and in severe cases, anaphylaxis [see Warnings and Precautions (5.1)].
- Insertional Oncogenesis: Inform patients and/or caregivers about the possible risk of insertional oncogenesis and development of malignancies with ZEVASKYN application [see Warnings and Precautions (5.2)].
- Transmission of Infectious Agents: Inform patients and/or caregivers about the possible risk of transmission of infectious agents with ZEVASKYN application [see Warnings and Precautions (5.3)].
- Post-application care:
- Expect pain and itching at the treatment site during the healing process. Contact the treating physician if experiencing fever, increased drainage, worsening pain and/or swelling or any other adverse effect at or around the treatment site
- Do not disturb the surgical dressing covering the ZEVASKYN epidermal sheet for 5-10 days. Leave the post-procedure surgical dressing in place unless instructed otherwise by the treating physician
- Keep the dressing(s) dry. Do not submerge treated sites in water until the gauze of the ZEVASKYN falls off the treatment site. Gauze backing should fall off within 2-3 weeks of ZEVASKYN surgical application
- Manufacturing Failure: Inform patients and/or caregivers that manufacturing failure may occur with autologous products. In case of a manufacturing failure, a second manufacturing of ZEVASKYN could be attempted with a new biopsy [see How Supplied (16.1)].
Manufactured and Distributed by:
© 2025 Abeona Therapeutics Inc. All rights reserved.
8PRINCIPAL DISPLAY PANEL
prademagene zamikeracel
