Improving DxMultiomics, Powered by Your Choices

We're building DxMultiomics to be The Central Nexus of Biotech Intelligence. To ensure a seamless experience and continuous improvement, we utilize website analytics. These tools help us monitor site performance, understand how users navigate the platform, and identify opportunities to make your research journey more efficient. We handle this data with the utmost respect for your privacy, and you can choose what works best for you.

Krystal Biotech Announces FDA Approval of Updated VYJUVEK® Label
_↗ ir.krystalbio.com
News Image

An expanded label for its gene therapy, VYJUVEK® (beremagene geperpavec-svdt), has been approved by the U.S. Food and Drug Administration (FDA), Krystal Biotechannounced. The updated label now allows for the treatment of dystrophic epidermolysis bullosa (DEB) patients from birth, and also provides greater flexibility for patients and caregivers in managing the therapy. This includes the ability for VYJUVEK to be applied at home by patients or their caregivers, making it easier to integrate into existing routines. The new label also permits wound dressings to be removed as part of the next dressing change, eliminating the previous 24-hour waiting period. announced. The updated label now allows for the treatment of dystrophic epidermolysis bullosa (DEB) patients from birth, and also provides greater flexibility for patients and caregivers in managing the therapy. This includes the ability for VYJUVEK to be applied at home by patients or their caregivers, making it easier to integrate into existing routines. The new label also permits wound dressings to be removed as part of the next dressing change, eliminating the previous 24-hour waiting period.

According to Krish S. Krishnan, Chairman and CEO of Krystal Biotech, these changes solidify VYJUVEK’s position as a leading treatment for DEB by making it more convenient and flexible. This is expected to improve patient compliance and reinforce the therapy as the new standard of care for DEB wounds, regardless of their size or severity. The company stated that the label update is based on real-world data collected since the drug's U.S. launch, as well as results from an open-label extension study. These findings collectively confirm the long-term safety and efficacy of VYJUVEK across all patient ages, even when administered by a patient or caregiver. VYJUVEK is a non-invasive, topical, and redosable genetic medicine designed to deliver two copies of the COL7A1 gene directly to DEB wounds, providing a template for the skin to produce normal COL7 protein and address the disease at a molecular level. The most common side effects include itching, chills, redness, and a runny nose.

Log In
Sign Up