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A Phase I/II Study of KB103, a Non-Integrating, Replication-Incompetent HSV Vector Expressing the Human Collagen VII Protein, for the Treatment of Dystrophic Epidermolysis Bullosa (DEB)

Trial Profile

A Phase I/II Study of KB103, a Non-Integrating, Replication-Incompetent HSV Vector Expressing the Human Collagen VII Protein, for the Treatment of Dystrophic Epidermolysis Bullosa (DEB)

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 04 Dec 2023

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At a glance

  • Drugs Beremagene geperpavec (Primary)
  • Indications Epidermolysis bullosa dystrophica
  • Focus Adverse reactions; First in man; Registrational; Therapeutic Use
  • Acronyms GEM-1; GEM-2
  • 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, announced the US Food and Drug Administration (FDA) has approved VYJUVEK for the treatment of patients six months of age or older with dystrophic epidermolysis bullosa based on the data from GEM1/2 & GEM 3. Krystal Biotech was also awarded a Rare Pediatric Disease Priority Review Voucher, which it can use to assign priority review status to a subsequent drug application.
    • 08 May 2023 According to a Krystal Biotech media release, the company began labeling discussions with the FDA.
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