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FDA Approves Zevaskyn Gene Therapy for Healing Large Epidermolysis Bullosa Wounds

VIITAL study results demonstrate durable wound closure with prademagene zamikeracel in patients with recessive dystrophic EB

Overview

  • Phase 3 VIITAL trial showed 81% of chronic EB wounds treated with Zevaskyn achieved at least 50% closure by week 24 versus 16% with standard care
  • Zevaskyn recipients experienced nearly three times the pain relief reported by control participants over the same period
  • The therapy works by modifying patients’ own skin cells to deliver a functional COL7A1 gene and correct the genetic defect in recessive dystrophic EB
  • Stanford researchers highlight the potential of this gene-corrected skin graft platform for other genetic diseases and aim to study its effects in younger patients
  • Availability is expected to be limited to select centers and may hinge on insurance approval, raising concerns over equitable access