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: 05 May 2025
Price :
$35
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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
- 28 Apr 2025 According to a Krystal Biotech media release, based on result form GEM-1 and GEM-3 studies further supported by open label extension study and real-world experience in the United States, the European Commission granted marketing authorization to beremagene geperpavec-svdt for the treatment of wounds in patients with dystrophic epidermolysis bullosa who have mutations in the collagen type VII alpha 1 chain (COL7A1) gene, starting from birth.
- 28 Feb 2025 According to a Committee for Medicinal Products for Human Use (CHMP) media release, The CHMP, EMAs human medicines committee, agreed with the CAT assessment and positive opinion, and recommended approval of this medicine. The opinion adopted by the CHMP is an intermediary step on Vyjuvek path to patient access. The opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorization. Once a marketing authorization has been granted.
- 28 Feb 2025 According to a Committee for Medicinal Products for Human Use (CHMP) media release, EMA has recommended granting a marketing authorisation in the European Union (EU) for Vyjuvek (beremagene geperpavec) to treat wounds in patients of all ages with dystrophic epidermolysis bullosa (DEB).