ZEVASKYN (Prademagene Zamikeracel)

ZEVASKYN (prademagene zamikeracel) is a gene therapy approved by the US FDA on 28 April 2025 for the treatment of wounds in adults and children with recessive dystrophic epidermolysis bullosa (RDEB). In RDEB, both copies of the COL7A1 gene are faulty, so the skin lacks collagen VII, the protein that anchors the outer skin layer. The skin blisters and tears with minor friction and leaves large, painful wounds that may stay open for years.

Each treatment is made from the patient’s own skin. Two small punch biopsies are taken, and in the manufacturer’s facility the skin cells receive a working copy of COL7A1 through a retroviral vector. They are then grown, over about 25 days, into thin sheets that make functional collagen VII. A surgeon stitches the sheets onto selected wounds in a single operation.

In the VIITAL study, 86 chronic wounds in 11 patients were paired, and one wound of each pair was treated with ZEVASKYN while the other received standard dressings. After 6 months, 81% of treated wounds had healed by at least half compared with 16% of control wounds, and wound pain scores fell more with ZEVASKYN. Abeona describes it as the first autologous cell-based gene therapy for RDEB wounds.

Another cultured-cell skin product on our site is Gintuit, though it is made from donor cells and is used for a different purpose.

• There are no contraindications listed in the US label.
• Serious allergic reactions can occur to vancomycin, amikacin or other materials used in production. Signs include itching, swelling, hives and breathing difficulty.
• The retroviral vector inserts into the cells’ DNA, so a cancer caused by this insertion is a theoretical risk. Patients are monitored for life, and the FDA has asked for a 15-year follow-up study.
• Because human and bovine reagents are used in manufacturing, transmission of infectious agents cannot be ruled out completely.
• In the study, the most common side effects were pain related to the procedure (27%) and itching (9%).
• There are no data in pregnancy; contraception is advised at the time of treatment. It has not been studied in people aged 65 or older.

Can ZEVASKYN be imported to India and applied here?

No. Each batch is made from the patient’s own cells in Cleveland, USA, lasts only 84 hours after it is sealed, and is applied by a surgical team at a US Qualified Treatment Centre with the manufacturer’s staff present. Treatment currently means travelling to one of these centres.

What will the treatment centre ask for?

• Genetic report confirming RDEB (mutations in both copies of COL7A1)
• Dermatologist’s summary with photographs and the size and duration of the wounds to be treated
• Record of infections, wound care and any history of skin cancer
• Passport details of the patient and caregiver

What does the process involve?

Skin biopsies are taken first. About 25 days later the sheets are ready and are applied under anaesthesia after the wounds are cleaned. The treated areas must stay undisturbed for 5 to 10 days, and the gauze backing falls off within 2 to 3 weeks. If manufacturing fails, a repeat biopsy is needed.

How many wounds can be treated?

Each sheet covers 41.25 cm² and up to 12 sheets can be applied in one session. The surgeon chooses which wounds to treat; in the main study patients received between 3 and 6 sheets.

ZEVASKYN is a personalised gene therapy and is not something IPN can stock or courier. What we can do is share the official information with the family and their dermatologist, contact the manufacturer about eligibility for patients from outside the USA, and help prepare the medical documents that a treatment centre will request. Abeona has not published a price.

To ask about ZEVASKYN treatment for an RDEB patient: Call +91 96548 60915, WhatsApp +91 93100 90915 or email info@indianpharmanetwork.in.

Global Approval Status:

• United States: FDA approval on 28 April 2025 (BLA 125807; priority review, Orphan Drug, Rare Pediatric Disease, Breakthrough Therapy and RMAT designations).
• European Union: Orphan designation only (EU/3/17/1835); no marketing authorisation as of October 2026.
• India: Not approved by CDSCO.

Sources:

• ZEVASKYN Package Insert (FDA)
• FDA approval letter, BLA 125807
• FDA Summary Basis for Regulatory Action
• Abeona Therapeutics: FDA approves ZEVASKYN (29 April 2025)
• ZEVASKYN Qualified Treatment Centers (Abeona)

Information last checked: October 2026.

What is ZEVASKYN used for?

Treating wounds in children and adults with recessive dystrophic epidermolysis bullosa (RDEB).

Is it a cream or an injection?

Neither. It is a set of thin sheets of the patient’s own gene-corrected skin cells, stitched onto wounds during surgery.

How is it different from Vyjuvek?

Vyjuvek, approved in 2023, delivers the COL7A1 gene with a modified herpes simplex virus vector. ZEVASKYN instead uses sheets grown from the patient’s own gene-corrected skin cells, applied in a single surgical session.

Where is ZEVASKYN given?

Only at Qualified Treatment Centres in the USA chosen by Abeona, such as Stanford Medicine Children’s Health and Children’s Hospital Colorado.

Who makes ZEVASKYN?

Abeona Therapeutics Inc., at its facility in Cleveland, Ohio.

When did the FDA approve ZEVASKYN?

On 28 April 2025.