VYJUVE® (beremagene geperpavec-svdt)
VYJUVEK® (beremagene geperpavec-svdt) (VYEJOO-VEK), developed by Krystal Biotech, is the first FDA-approved treatment to address the genetic cause of dystrophic Epidermolysis Bullosa (DEB).
The topical gel containing an HSV vector expressing a full-length, functional human COL7A1 enables skin cells to produce functional Collagen VII protein and promotes wound healing and skin stability.
VYJUVE® is approved as topical gel for dystrophic Epidermolysis Bullosa patients 6 months of age or older. Only a healthcare professional should apply VYJUVEK™ at a healthcare professional setting (I.e. clinic) or home setting, depending on your doctor’s instructions, your insurance plan coverage, and your preference.
Approved by | Date of Approval | Therapeutic Approach | Route of Administration | EB Subtype |
FDA | May 2023 | Gene therapies and combined gene/cell therapies | Topical | DEB |
Please note that a marketing authorisation by a national or international regulatory authority (European Medicines Authority [EMA], Food and Drug Administration [FDA] etc.) does not indicate whether the therapy or medication is available in a particular country or is reimbursed by a health insurance fund.
Related links
First gene therapy for DEB patients approved in the US - EB-Research (eb-researchnetwork.org)
Krystal Biotech B-VEC awaiting approval by FDA - EB-Research (eb-researchnetwork.org)
Krystal announces positive Phase 3 results - EB-Research (eb-researchnetwork.org)
Krystal Phase 1/2 Publication in Nature - EB-Research (eb-researchnetwork.org)