Krystal Biotech Announces Approval of VYJUVEK® by Japan's Ministry of Health, Labour and Welfare for the Treatment of Dystrophic Epidermolysis Bullosa

Core Insights - VYJUVEK has received marketing authorization in Japan for the treatment of dystrophic epidermolysis bullosa (DEB) starting from birth, marking it as the first genetic medicine approved for this condition in the country [1][5] - The approval allows for flexible administration options, including home dosing and administration by patients or their family members, which is a significant advancement in treatment accessibility [1][3] - The company anticipates launching VYJUVEK in Japan by the end of 2025, pending the completion of reimbursement procedures [4][7] Company Overview - Krystal Biotech, Inc. is a global biotechnology company focused on developing genetic medicines for diseases with high unmet medical needs, with VYJUVEK being its first commercial product [8][9] - The company has a robust pipeline of investigational genetic medicines across various therapeutic areas, including respiratory, oncology, dermatology, ophthalmology, and aesthetics [8][9] Regulatory and Clinical Insights - The approval by Japan's Ministry of Health, Labour and Welfare (MHLW) was based on a comprehensive clinical dataset, including results from an open-label extension study in Japanese patients, which showed that all four patients achieved full wound closure at six months [5][6] - VYJUVEK was previously approved by the FDA in the United States in May 2023 and by the European Commission in April 2025, indicating a growing recognition of its therapeutic potential [7]