VYJUVEK

STN: 125774
Proper Name: beremagene geperpavec-svdt
Tradename: VYJUVEK
Manufacturer: Krystal Biotech, Inc.
Indication:

• For the treatment of wounds in adult and pediatric patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.

Product Information

• Package Insert - VYJUVEK
• Instruction For Use - VYJUVEK
• Medication Guide - VYJUVEK
• Demographic Subgroup Information – VYJUVEK
  Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.

Supporting Documents

• September 12, 2025 Approval Letter - VYJUVEK
• August 7, 2023 Approval Letter - VYJUVEK
• May 19, 2023 Approval Letter - VYJUVEK
• Summary Basis for Regulatory Action - VYJUVEK
• Approval History, Letters, Reviews, and Related Documents - VYJUVEK