Krystal Biotech Secures FDA Clearance For Updated VYJUVEK® Label

Krystal Biotech, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a label update for VYJUVEK (beremagene geperpavec-svdt) that broadens its use to include patients with dystrophic epidermolysis bullosa (DEB) from birth. The update also gives patients and caregivers full flexibility in how VYJUVEK is applied and in managing wound dressings.

With this change, DEB patients and their caregivers can now apply VYJUVEK themselves at home, making treatment more convenient and accessible. The updated label also allows greater flexibility in wound care by permitting dressings to be removed during the next scheduled change, rather than requiring a 24-hour wait. This adjustment makes it easier to incorporate VYJUVEK into patients’ existing wound care routines.

Krish S. Krishnan, Chairman and CEO of Krystal Biotech, stated, “We believe these changes further reinforce VYJUVEK’s leadership position as the most flexible, convenient, and disease modifying medicine to treat DEB patients in the United States. Moreover, by providing patients and their caregivers the ability to apply VYJUVEK themselves, we have made it easier for patients to integrate VYJUVEK into their daily routines and lifestyle. Overall, we believe that these advancements solidify VYJUVEK as the standard of care for all DEB wounds, regardless of wound size and severity, and will further improve compliance.”

Brett Kopelan, Executive Director of debra of America, mentioned, “The updates to the VYJUVEK label are yet another significant and impactful step forward for all those living with DEB. Enabling caretakers to apply VYJUVEK during their standard of care regimen is an enormous positive change allowing for increased convenience without sacrificing safety. The Krystal team has always prioritized patient safety and convenience when it comes to the use of VYJUVEK and advocating for these updates is not surprising given Krystal’s patient centric approach. This aspect of the update to the label will only increase the quality of life of those living with this challenging disorder and that is exactly what our community needs.”

The FDA’s decision is supported by real-world evidence gathered since VYJUVEK’s launch in the United States, along with results from an open-label extension study conducted in the country and published earlier this year. These findings confirm the long-term safety and effectiveness of VYJUVEK across all age groups, including situations where the treatment is applied by patients or caregivers. Krystal Biotech emphasized that this update represents an important step toward improving quality of life for people living with DEB by simplifying treatment and wound management.