The U.S. Food and Drug Administration (FDA) approved a label update for beremagene geperpavec-svdt (Vyjuvek, Krystal Biotech, Inc.) that expands the eligible patient population to include dystrophic epidermolysis bullosa (DEB) patients from birth and provides patients full flexibility with respect to application and managing wound dressings.
In addition to allowing DEB patients and their caregivers to apply beremagene geperpavec-svdt at home on their own, the label update also affords patients greater flexibility in managing wound dressings. Wound dressings are now permitted to be removed as part of the next dressing change rather than waiting 24 hours, further integrating beremagene geperpavec-svdt into existing wound care routines.
This label update is based on real-world data collected since the beremagene geperpavec-svdt launch in the United States, as well as results from the open label extension study conducted in the United States and published earlier this year, which collectively reinforce the long-term safety and efficacy of beremagene geperpavec-svdt across patients of all ages, including in cases of patient or caregiver application.
“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,” says Krish S. Krishnan, Chairman and CEO of Krystal Biotech, in a news release. “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.”
“The updates to the VYJUVEK label are yet another significant and impactful step forward for all those living with DEB,” adds Brett Kopelan, Executive Director of debra of America. “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 them 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.”
