FDA Approves Zevaskyn for Rare, Genetic Skin Disorder

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The U.S. Food and Drug Administration has approved Zevaskyn (prademagene zamikeracel) for patients with the rare, genetic skin disorder recessive dystrophic epidermolysis bullosa.

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.

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.

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.

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.

“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.”

Approval of Zevaskyn was granted to Abeona Therapeutics.

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Source: HealthDay

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