Krystal Biotech receives positive CHMP opinion for VYJUVEK

Krystal Biotech (KRYS) welcomed the European Medicines Agency’s announcement that its Committee for Medicinal Products for Human Use has issued a positive recommendation for the European Commission to approve VYJUVEK for the treatment of wounds in patients with dystrophic epidermolysis bullosa who have mutations in the collagen type VII alpha 1 chain gene, starting from birth. The CHMP’s positive opinion includes support for administration of VYJUVEK in either a health care setting or at home. If deemed appropriate by a healthcare professional, trained patients or caregivers may also apply VYJUVEK. The final EC decision is anticipated in the second quarter of 2025. The decision will be applicable to all European Union member states, as well as Iceland, Norway and Liechtenstein.