FDA
Vyjuvek now approved for use in younger children
FDA has approved a label update for Vyjuvek (beremagene geperpavec-svdt) that expands the eligible patient population to include dystrophic epidermolysis bullosa (DEB) patients from birth. Vyjuvek may now be applied by patients or caregivers at home. In addition, wound dressings are now permitted to be removed as part of the next dressing change rather than waiting 24 hours.
Vyjuvek, a genetically modified herpes-simplex virus used to deliver normal copies of the COL7A1 gene to DEB wounds, was first approved in 2023. Previously, it had been indicated for patients ≥6 months of age with a requirement for application by an HCP in a health care setting.
Sources:
Krystal Biotech announces FDA approval of updated Vyjuvek® label [News release]. 2025. https://ir.krystalbio.com/news-releases/news-release-details/krystal-biotech-announces-fda-approval-updated-vyjuvekr-label
Vyjuvek (beremagene geperpavec-svdt) [package insert]. Krystal Biotech. https://www.krystallabel.com/pdf/vyjuvek-us-pi.pdf Revised September 2025. Accessed September 18, 2025.