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A Phase III Efficacy and Safety Study of Beremagene Geperpavec (B-VEC, Previously "KB103") for the Treatment of Dystrophic Epidermolysis Bullosa (DEB)

Trial Profile

A Phase III Efficacy and Safety Study of Beremagene Geperpavec (B-VEC, Previously "KB103") for the Treatment of Dystrophic Epidermolysis Bullosa (DEB)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Dec 2023

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At a glance

  • Drugs Beremagene geperpavec (Primary)
  • Indications Epidermolysis bullosa dystrophica
  • Focus Registrational; Therapeutic Use
  • Acronyms GEM-3
  • Sponsors Krystal Biotech
  • Most Recent Events

    • 27 Nov 2023 According to a Krystal Biotech media release, the EMA has validated Marketing Authorization Application (MAA) of VYJUVEK for the Treatment of Dystrophic Epidermolysis Bullosa and is under CHMP review. A CHMP opinion is anticipated in the second half of 2024.
    • 19 May 2023 According to a Krystal Biotech media release, the U.S. Food and Drug Administration approved Vyjuvek for the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.
    • 08 May 2023 According to a Krystal Biotech media release, the company was informed by the European Medicines Agency in January 2023 to modify the Pediatric Investigation Plan (PIP) waiver request to include patients between birth and 6 months. The Company has modified and submitted the PIP waiver so that the Marketing Authorization Application procedure can officially start in the second half of 2023 with an approval expected in early 2024.
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