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Open Label Extension Protocol (Japan):Assess the Efficacy and Safety of Beremagene Geperpavec (B-VEC, previously KB103) for the Treatment of Japanese Patients with Dystrophic Epidermolysis Bullosa (DEB)

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Trial Profile

Open Label Extension Protocol (Japan):Assess the Efficacy and Safety of Beremagene Geperpavec (B-VEC, previously KB103) for the Treatment of Japanese Patients with Dystrophic Epidermolysis Bullosa (DEB)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2025

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At a glance

  • Drugs Beremagene geperpavec (Primary)
  • Indications Epidermolysis bullosa dystrophica
  • Focus Adverse reactions; Registrational
  • Sponsors Krystal Biotech

Most Recent Events

  • 01 Oct 2025 Primary endpoint has been met (Wound healing assessments on a primary wound).
  • 01 Oct 2025 Results evaluating efficacy and safety of the topical gene therapy beremagene geperpavec-svdt (B-VEC) published in the Journal of Dermatology.
  • 15 Sep 2025 According to a Krystal Biotech media release, the company announced that the US FDA approved a label update for VYJUVEK, expanding its use to dystrophic epidermolysis bullosa patients from birth and provides patients full flexibility with respect to VYJUVEK application and managing wound dressings. This label update is based on real-world data collected since VYJUVEK launch in US, and results from the open label extension study conducted in the US and published earlier this year.

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