KRYS Gets Positive CHMP Opinion for EU Approval of Skin Disease Drug

Krystal Biotech (KRYS) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Vyjuvek (beremagene geperpavec-svdt, or B-VEC) for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB). The intended DEB patient population includes those who have mutations in the COL7A1 gene starting from birth.DEB is a rare and severe monogenic disease that affects the skin and mucosal tissues. I ...