VYJUVEK
STN: 125774
Proper Name: beremagene geperpavec
Tradename: VYJUVEK
Manufacturer: Krystal Biotech, Inc.
Indication:
- For the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.
Product Information
- Package Insert - 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
- 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