UK MHRA approves Vyjuvek for dystrophic epidermolysis bullosa from birth – Krystal Biotech
Krystal Biotech announced that, on May 15, 2026, the United Kingdom MHRA granted marketing authorization to Vyjuvek (beremagene geperpavec-svdt) for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene, from birth.
Vyjuvek is the first genetic medicine approved in the United Kingdom for the treatment of DEB and is designed to address the root cause of the disease by delivering functional copies of the human COL7A1 gene to provide wound healing and sustained functional type VII collagen protein expression with redosing. The approval in the United Kingdom also includes flexible administration options similar to those granted in the United States, European Union, and Japan, allowing for dosing at home or in a healthcare setting, with the option for administration by patients or their caregivers.
Vyjuvek also fulfilled the United Kingdom Orphan Designation criteria and will be added to the Orphan Register held by the MHRA, allowing it to benefit from up to 12 years of market exclusivity.
The approval of Vyjuvek by the MHRA was based on a comprehensive clinical dataset including results from the Company’s Phase 1/2 GEM-1 and Phase 3 GEM-3 studies, which collectively provided clear clinical evidence of successful COL7A1 gene delivery and durable wound closure following topical administration, and was further supported by results from the Company’s open label extension study and real-world experience with Vyjuvek.
The timing for launch of Vyjuvek in the United Kingdom will depend on completion of reimbursement procedures currently underway.
Vyjuvek was previously approved by the Food and Drug Administration in the United States in May 2023, the European Commission in April 2025, and Japan’s Ministry of Health, Labour and Welfare in July 2025.
