Vyjuvek FDA Approval History
Last updated by Judith Stewart, BPharm on May 22, 2023.
FDA Approved: Yes (First approved May 19, 2023)
Brand name: Vyjuvek
Generic name: beremagene geperpavec-svdt
Dosage form: Topical Gel
Company: Krystal Biotech, Inc.
Treatment for: Epidermolysis Bullosa
Vyjuvek (beremagene-geperpavec-svdt) is a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy for the treatment of wounds in patients dystrophic epidermolysis bullosa.
- Vyjuvek is indicated 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.
- Dystrophic Epidermolysis Bullosa (DEB) is a serious rare genetic disease that affects the skin and mucosal tissues. It is characterized by blistering of the hands, feet, knees, and elbows. It is caused by one or more mutations in the COL7A1 gene, resulting in lack of production of functional type VII collagen (COL7) protein.
- Vyjuvek is a gene therapy in the form of a biological suspension which is mixed into excipient gel, for topical application. It works to treat DEB by restoring functional copies of the COL7A1 gene.
- Vyjuvek is a topical gel that is applied to the wounds of patients with DEB once a week.
- Warnings and precautions associated with Vyjuvek include accidental exposure. Direct contact with treated wounds and dressings of treated wounds should be avoided for approximately 24 hours following application.
- Common adverse drug reactions include itching, chills, redness, rash, cough, and runny nose.
Development timeline for Vyjuvek
| Date | Article |
|---|---|
| May 19, 2023 | Approval FDA Approves Vyjuvek (beremagene geperpavec-svdt) Redosable Gene Therapy for the Treatment of Dystrophic Epidermolysis Bullosa |
Further information
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