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: 04 Jun 2026

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At a glance

18 May 2026 According to a Krystal Biotech media release, company announced that on 15 MAY the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization to VYJUVEK (beremagene geperpavec-svdt) for the treatment of wounds in patients with dystrophic epidermolysis bullosa based on results from GEM-1, GEM-3 studies and open label extension study and real-world experience with VYJUVEK..
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.

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