Krystal Biotech announces UK MHRA approval of Vyjuvek

Krystal Biotech (KRYS) announced that the United Kingdom Medicines and Healthcare products Regulatory Agency, or MHRA, granted marketing authorization to Vyjuvek for the treatment of wounds in patients with dystrophic epidermolysis bullosa with mutations in the collagen type VII alpha 1 chain 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.