Krystal Biotech's VYJUVEK approved in Japan for dystrophic epidermolysis bullosa

Krystal Biotech, Inc.

Japan's MHLW granted marketing authorization for VYJUVEK on July 24, 2025 for DEB from birth.
First genetic medicine approved in Japan for DEB; allows home dosing and administration by patients or family.
Based on Phase 3 data and Japanese open-label extension; all 4 patients achieved full wound closure at 6 months.
Re-examination period is 10 years; launch expected in Japan by end of 2025.
Previously approved in US (May 2023) and EU (April 2025).

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