Krystal Biotech (KRYS) said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended European Commission (EC) approval of Vyjuvek for the treatment of wounds in patients with dystrophic epidermolysis bullosa.
The indication is specifically for patients with the genetic skin disorder who have mutations in the collagen type VII alpha 1 chain gene starting from birth, the company said.
The opinion supports administration of the drug, also called beremagene geperpavec-svdt, either at a clinic or at home by healthcare professionals or trained patients or caregivers, the company said.
A final decision by the European Commission is expected in Q2, the company said.
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