Commercial-stage biotechnology company Krystal Biotech Inc (NASDAQ:KRYS) announced on Monday that the US Food and Drug Administration (FDA) has approved a label update for VYJUVEK (beremagene geperpavec-svdt).

This update expands the eligible patient population to include dystrophic epidermolysis bullosa (DEB) patients from birth.

Additionally, the revised label allows patients and caregivers to apply VYJUVEK at home and provides greater flexibility in managing wound dressings, permitting removal during the next dressing change instead of waiting 24 hours. This integration simplifies treatment within existing wound care routines.

The approval is supported by real-world data collected since VYJUVEK's US launch and findings from an open-label extension study published earlier in 2025. The data reinforce the long-term safety and efficacy of VYJUVEK across all ages, including when applied by patients or caregivers.

VYJUVEK is a non-invasive, topical, redosable genetic medicine designed to deliver two copies of the COL7A1 gene when applied directly to DEB wounds. The treatment was designed to treat DEB at the molecular level by providing the patient's skin cells the template to make normal COL7 protein, thereby addressing the fundamental disease-causing mechanism. VYJUVEK is approved in the United States, Europe, and Japan.