Krystal Biotech, Inc. (KRYS) Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of Vyjuvek for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB)
Dystrophic epidermolysis bullosa is a genetic disorder affecting the skin and other organs.
Final decision by the European Commission is expected in the second quarter of 2025.
The CHMP positive opinion was based on results from Phase 1/2 GEM-1 and Phase 3 GEM-3 studies, which provided clear evidence of durable wound closure following administration of Vyjuvek.
Vyjuvek, a topical gene therapy, is already approved by the FDA for the treatment of wounds in patients with DEB.
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