Krystal Biotech gains UK approval for VYJUVEK gene therapy

Krystal Biotech Inc. (NASDAQ: KRYS) announced that the United Kingdom Medicines and Healthcare products Regulatory Agency granted marketing authorization for VYJUVEK on May 15 for treating wounds in patients with dystrophic epidermolysis bullosa who have mutations in the COL7A1 gene.

VYJUVEK represents the first genetic medicine approved in the United Kingdom for dystrophic epidermolysis bullosa treatment. The therapy delivers functional copies of the human COL7A1 gene to provide wound healing and sustained functional type VII collagen protein expression with redosing capability.

The UK approval includes flexible administration options allowing for dosing at home or in healthcare settings, with administration possible by patients or caregivers. These options mirror those already granted in the United States, European Union, and Japan.

The drug fulfilled United Kingdom Orphan Designation criteria and will receive up to 12 years of market exclusivity. The approval was based on clinical data from the company's Phase 1/2 GEM-1 and Phase 3 GEM-3 studies, along with open label extension study results and real-world experience.

VYJUVEK received previous approvals from 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.

The timing for VYJUVEK's launch in the United Kingdom depends on completion of ongoing reimbursement procedures, according to the company's statement.

The approved indication covers treatment of wounds in patients with dystrophic epidermolysis bullosa with COL7A1 gene mutations from birth.

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