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# Krystal Wins Expanded Label for Gene Therapy
- URL: https://www.fdaweb.com/krystal-wins-expanded-label-for-gene-therapy/
- Published: 2025-09-15T12:00:00.000Z
- Updated: 2026-09-14T15:21:39.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5159866

FDA has approved a Krystal Biotech supplemental BLA for a label expansion on its gene therapy Vyjuvek (beremagene geperpavec-svdt), adding patients with dystrophic epidermolysis bullosa (DEB) from birth. The labeling now allows DEB patients and their caregivers to apply the topical gene therapy at home, rather than requiring administration in a clinical setting, the company says. It also changes wound care guidelines, permitting dressings to be removed during the next scheduled change instead of after 24 hours.

Krystal says the expanded label is based on real-world data accumulated since the drug’s 2023 launch and findings from an open-label extension study published earlier this year, which confirmed Vyjuvek’s long-term safety and effectiveness across patient groups, including when administered by caregivers.