Zevaskyn (prademagene zamikeracel)

A one-time gene therapy made from a patient's own skin cells, approved by the FDA on April 28, 2025 for wounds in adults and children with recessive dystrophic epidermolysis bullosa (RDEB). The cells are gene-corrected in a lab, grown into credit card-sized sheets and stitched onto chronic wounds during surgery. In its main trial, 81% of treated wounds were at least half healed at 6 months, against 16% of matched wounds given standard wound care.

In recessive dystrophic EB, both copies of the COL7A1 gene are changed, so the skin makes little or no working type VII collagen, the protein that forms anchoring fibrils holding the top layer of skin to the layer below. To make Zevaskyn, doctors take small skin punch biopsies, and in a lab the patient's skin cells receive a working copy of COL7A1 from a retroviral vector, a disabled virus that places the gene into the cells' DNA. The corrected cells are grown into sheets that make type VII collagen, and the sheets are sewn onto wounds. In an earlier study, the collagen or anchoring fibrils were found in treated skin in 6 of 7 patients at 3 months, 5 at 6 months and 3 at 1 year.

Zevaskyn has no boxed warning and no contraindications. In the VIITAL trial of 11 patients, the most common side effects were pain from the procedure (27%, 3 patients) and itching (9%, 1 patient); the label has no placebo comparison because each patient's own untreated wounds served as the control. The label warns of possible severe allergic reactions, including anaphylaxis, to the antibiotics vancomycin or amikacin or to other product ingredients. Because the retroviral vector places the gene into cell DNA, there is a possible risk that it could trigger cancer (insertional oncogenesis), so patients should be monitored for cancers for the rest of their lives. It is made with human and cow-derived materials, so passing on an infection cannot be completely ruled out^[1].

Zevaskyn is a one-time surgical treatment given at a Qualified Treatment Center. Skin biopsies are taken first, and Abeona says the sheets take about 25 days to make^[9]. Up to 12 sheets, each 5.5 cm by 7.5 cm (41.25 square centimeters), can be made, and all chosen sheets are applied in a single operation under general or other anesthesia. The wound is cleaned (debrided), the sheets are sewn on with dissolving stitches without trimming or overlapping, and the area is covered with non-stick dressings and antibiotic ointment. The treated area should be left undisturbed for 5 to 10 days and kept dry until the gauze backing falls off, usually within 2 to 3 weeks. The sheets must be used within 84 hours of manufacture, and if manufacturing fails, a new biopsy is needed to try again^[1]. Abeona says patients stay at the treatment center for 5 to 10 days after surgery^[9].

Yes, Prademagene zamikeracel (Zevaskyn) is FDA approved (2025) for the treatment of Epidermolysis Bullosa.

Both deliver a working COL7A1 gene, but in different ways. Vyjuvek is a gel containing a disabled herpes virus that is dripped onto wounds every week, at home or in a clinic, and it is approved for dominant and recessive dystrophic EB. Zevaskyn is made from your own skin cells, corrected in a lab and sewn onto wounds in a single surgery at a treatment center, and it is approved for recessive dystrophic EB. No trial has compared them.

Abeona says manufacturing takes about 25 days after the skin biopsy. Patients then return to the Qualified Treatment Center for surgery and stay about 5 to 10 days while the treated areas are kept still. The finished sheets must be used within 84 hours of being made.

The most common side effects in the main trial were pain from the procedure and itching. The label also warns about severe allergic reactions to vancomycin, amikacin or product ingredients, a possible risk of cancer because the vector places the gene into cell DNA, which is why lifelong cancer monitoring is advised, and a small risk of infection from the human and animal materials used in manufacturing.