Krystal Biotech Announces FDA Approval of Updated VYJUVEK® Label

Core Viewpoint - The FDA has approved a label update for VYJUVEK, expanding its eligible patient population to include dystrophic epidermolysis bullosa (DEB) patients from birth, allowing for greater flexibility in application and wound management [2][3]. Group 1: Product and Application - VYJUVEK is a non-invasive, topical, redosable genetic medicine designed to deliver two copies of the COL7A1 gene directly to DEB wounds, addressing the disease-causing mechanism at the molecular level [5]. - The updated label allows DEB patients and caregivers to apply VYJUVEK at home, integrating it into daily routines and enhancing convenience [3][4]. - Wound dressings can now be removed during the next dressing change rather than waiting 24 hours, further streamlining the wound care process [3]. Group 2: Company and Market Position - Krystal Biotech believes these updates reinforce VYJUVEK's leadership position as a flexible and convenient treatment for DEB patients in the U.S. [3]. - The label update is based on real-world data and results from an open-label extension study, supporting the long-term safety and efficacy of VYJUVEK across all ages [4]. - Krystal Biotech is a fully integrated biotechnology company focused on developing genetic medicines for diseases with high unmet medical needs, with VYJUVEK being its first commercial product [12].