Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Krystal Biotech Netherlands, B.V., Atrium Gebouw, Strawinskylaan 3051, Amsterdam 1077 ZX, Netherlands
Vyjuvek 5×109 plaque forming units/mL suspension and gel for gel.
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Suspension and gel for gel. The suspension is opalescent yellow to colourless following thaw from its frozen state. The gel is a clear viscous gel following thaw from its frozen state. |
Beremagene geperpavec is a replication-defective Herpes Simplex Type-1 HSV-1-based gene therapy vector that has been genetically modified to express the human type VII collagen (COL7) protein under the control of the human cytomegalovirus (hCMV) promoter.
Beremagene geperpavec is produced in Vero cells by recombinant DNA technology.
Each vial contains 1 mL extractable volume of suspension containing 5×109 plaque forming units (PFU) of beremagene geperpavec.
After mixing 1 mL of the suspension with the gel, Vyjuvek contains 5×109 PFU in 2.5 mL. Extractable volume is 2.0 mL (4×109 PFU).
For the full list of excipients, see section 6.1.
| Active Ingredient |
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Beremagene geperpavec is a gene therapy based on an engineered, replication-defective herpes simplex virus 1 (HSV-1) encoded with COL7A1 gene, addressing the underlying genetic cause of dystrophic epidermolysis bullosa. The HSV-1 vector belongs to the human herpes virus (HHV) family of double-stranded DNA viruses. Upon cutaneous application to the wounds, beremagene geperpavec can transduce both keratinocytes and fibroblasts. |
| List of Excipients |
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Suspension: Glycerol (E422) Gel: Hypromellose (E464) |
Each carton of Vyjuvek contains one vial of suspension and one vial of gel.
Suspension:
1 mL extractable volume containing 5×109 PFU in a cyclo-olefin copolymer vial with a thermoplastic elastomer closure and green cap.
Gel:
1.5 mL fill volume in a separate Type-1 glass vial with a bromobutyl elastomer stopper and blue cap.
Krystal Biotech Netherlands, B.V., Atrium Gebouw, Strawinskylaan 3051, Amsterdam 1077 ZX, Netherlands
EU/1/25/1918/001
| Drug | Countries | |
|---|---|---|
| VYJUVEK | United States |
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