Zevaskyn is the first and only autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa<\/p>\n<\/h3>\n
By Stephanie Brown HealthDay Reporter<\/b>
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TUESDAY, April 29, 2025 (HealthDay News) — The U.S. Food and Drug Administration has approved Zevaskyn (prademagene zamikeracel) for patients with the rare, genetic skin disorder recessive dystrophic epidermolysis bullosa.<\/p>\n
Zevaskyn is the first and only autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa, a skin condition characterized by extremely fragile skin that blisters and tears easily.<\/p>\n
FDA approval of Zevaskyn was based on findings from two clinical studies. In a single-center, open-label, phase 1\/2a study involving 38 chronic wounds in seven patients, a single surgical application of Zevaskyn demonstrated long-term improvement at the treated sites during a median seven-year follow-up period.<\/p>\n
In the multicenter, randomized, intrapatient-controlled, phase 3 VIITAL study, evaluating the effectiveness of a single application of Zevaskyn on 43 large, chronic wounds, 81 percent of wounds demonstrated 50 percent or greater healing after six months. This result was statistically significant when compared with a matched control group of 43 wounds treated with the standard of care, where only 16 percent achieved the same level of healing.<\/p>\n
Across both studies, Zevaskyn was well tolerated, and no treatment-related serious adverse events were reported. The most common nonserious adverse events reported were procedural pain and itch, which only appeared to affect about 5 percent of patients.<\/p>\n
“Based on the strength of our data across clinical trials, we are confident in Zevaskyn’s ability to deliver long-term results after a single treatment application,” Madhav Vasanthavada, Ph.D., chief commercial officer at Abeona Therapeutics, said in a statement. “We are committed to working closely with both commercial and government payers on outcome-based agreements that stand behind the promise of Zevaskyn for patients, and expedite access.”<\/p>\n
Approval of Zevaskyn was granted to Abeona Therapeutics.<\/p>\n