Japan Receives Approval of Krystal Biotech's VYJUVEK®

Krystal Biotech has announced that Japan’s Ministry of Health, Labour and Welfare has granted marketing authorisation to VYJUVEK® (beremagene geperpavec-svdt) for the treatment of wounds caused by dystrophic epidermolysis bullosa (DEB), effective from birth.

This approval makes VYJUVEK® the first genetic medicine authorised in Japan to treat DEB, and is designed to address the root cause of the disease by delivering functional copies of the human COL7A1 gene to provide wound healing and sustained functional type VII collagen protein expression with redosing. The Japanese approval allows for dosing at home or in a healthcare setting, with the option for administration by patients or their family members.

As per the approval issued by the MHLW, VYJUVEK® is intended for use only in patients with a definite diagnosis of dystrophic epidermolysis bullosa. Genetic testing is not a requirement for treatment.

The authorisation is supported by clinical data, including a Japanese open-label extension study in which all four participants achieved full wound closure by six months. These results were consistent with those from a Phase 3 trial in the United States.

Availability in Japan will follow completion of reimbursement procedures, with Krystal Biotech projecting launch by the end of 2025.

“For far too long, DEB patients in Japan have suffered from a lack of corrective therapies to manage their complex and often debilitating disease,” said Hiroshi Kasamoto, General Manager of Japan at Krystal Biotech. “The approval of VYJUVEK in Japan is a long-awaited and urgently needed breakthrough, offering the potential to dramatically improve the lives of DEB patients across the country. With this important milestone, we remain on track to commercially launch VYJUVEK in Japan later this year and bring this innovative therapy to the many hundreds of DEB patients in need.”

VYJUVEK was previously approved by the Food and Drug Administration in the United States in May 2023 and by the European Commission in April 2025.