Commercial-stage biotechnology company Krystal Biotech Inc (NASDAQ:KRYS) announced on Friday that Japan's Ministry of Health, Labour and Welfare has approved VYJUVEK for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB), beginning at birth.

This marks the first and only genetic medicine approved in Japan for DEB.

VYJUVEK delivers functional copies of the human COL7A1 gene to promote wound healing and sustained type VII collagen expression with repeat dosing. The therapy is approved for flexible administration, including home use and self- or caregiver administration.

The approval follows regulatory review and confirmation of environmental safety under Japan's Cartagena Act, making VYJUVEK the country's first genetic medicine authorised for home use. Genetic testing is not required for treatment eligibility.

Clinical data supporting approval included an open-label extension study in Japanese patients, which aligned with prior US Phase 3 results. All participants in the Japanese study achieved full wound closure at six months, and the safety profile remained consistent.

Commercial launch in Japan is expected by year-end, pending completion of reimbursement procedures.

VYJUVEK holds a ten-year re-examination period in Japan and was previously approved in the United States and European Union.