KRYS News & Events

Krystal Biotech 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.

The Medicines and Healthcare products Regulatory Agency has approved Krystal Biotech's beremagene geperpavec -- Vyjuvek -- for the treatment of wounds in patients with dystrophic epidermolysis bullosa. It can be used from birth onward. DEB is a rare genetic condition that makes the skin fragile and prone to blistering due to a fault in a gene responsible for holding skin layers together. Beremagene geperpavec is a gel, applied directly to wounds. In a study of 31 patients aged 1 to 44 years with dystrophic epidermolysis bullosa, beremagene geperpavec was shown to help heal wounds. At 6 months, 67% of wounds treated with the medicine were completely healed, compared with 22% of those treated with placebo.