Zevaskyn FDA Approval History
Last updated by Judith Stewart, BPharm on April 30, 2025.
FDA Approved: Yes (First approved April 29, 2025)
Brand name: Zevaskyn
Generic name: prademagene zamikeracel
Dosage form: Gene-Modified Cellular Sheets
Company: Abeona Therapeutics Inc.
Treatment for: Epidermolysis Bullosa
Zevaskyn (prademagene zamikeracel) is an autologous, cell sheet-based gene therapy for the treatment of recessive dystrophic epidermolysis bullosa.
- Zevaskyn is indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).
- RDEB is a rare connective tissue disorder caused by a defect in the COL7A1 gene, which results in the inability to produce functioning type VII collagen that helps anchor the dermal and epidermal layers of the skin. RDEB is characterized by skin that is fragile and blisters easily, leading to wounds that continually open and close, or fail to heal altogether. Severe skin wounds are large and painful and can lead to systemic infection.
- Zevaskyn works by incorporating the functional type VII collagen-producing COL7A1 gene into a patient’s own skin cells (keratinocytes), then transplanting them back to the patient to enable normal type VII collagen expression, which facilitates wound healing.
- FDA approval of Zevaskyn was based on the pivotal Phase 3 VIITAL study (NCT04227106) that demonstrated statistically significant healing of large chronic RDEB wounds, and pain reduction. Across 43 wounds treated with a single application of Zevaskyn, 81 percent of wounds showed 50 percent or more healing (P<0.0001) as evaluated at six months, compared to 16 percent in 43 matched control wounds treated with standard of care. The Phase 1/2a study (NCT01263379) of 38 wounds across 7 patients showed that a single surgical application of Zevaskyn was associated with long-term improvement at treated sites over a median follow-up of 6.9 years; range 4 to 8 years.
- Zevaskyn cellular sheets containing a patient's own gene-modified cells are administered surgically by topical application onto wounds.
- Warnings and precautions associated with Zevaskyn include hypersensitivity reactions to vancomycin, amikacin, or product excipients; retroviral vector (RVV)-mediated insertional oncogenesis; and transmission of infectious agents due to human- and bovine-derived reagents used during manufacturing.
- Common adverse reactions (incidence ≥5%) include procedural pain and pruritus.
Development timeline for Zevaskyn
Further information
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