Krystal Biotech Secures EU Approval for Vyjuvek Treatment

Krystal Biotech has received European Commission approval for Vyjuvek, marking it as the first corrective gene therapy for dystrophic epidermolysis bullosa (DEB) in Europe. Vyjuvek addresses the genetic cause of DEB, a condition causing skin blistering from birth, by delivering functional copies of the COL7A1 gene, which promotes wound healing and sustained collagen protein expression. The therapy allows for flexible dosing at home or in healthcare settings, with administration by patients or caregivers under professional guidance. The approval extends to all EU member states, Iceland, Norway, and Liechtenstein, with the first European launch planned for Germany in mid-2025. This milestone follows successful clinical trials and builds on Vyjuvek’s prior approval and commercial success in the United States. Krystal Biotech aims to expand access to DEB patients across Europe and continues to pursue regulatory approval in other markets, including Japan.