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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)

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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)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Dec 2024

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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

    • 09 Dec 2024 According to a Krystal Biotech media release, company announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) cancelled the Oral Explanation regarding the Company Marketing Authorization Application for beremagene geperpavec-svdt (B-VEC) for the treatment of dystrophic epidermolysis bullosa (DEB) that was scheduled for December 6, 2024, and asked the Company to submit written responses to the remaining outstanding issues.
    • 06 May 2024 According to a Krystal Biotech media release, the European Medicines Agency (EMA) completed inspections of the manufacturing facility as part of the EMA's review of the Marketing Authorization Application (MAA) for B-VEC for the treatment of DEB in patients from birth. GMP certification and a decision on the MAA are both anticipated in 2H 2024.
    • 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.

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