Vyjuvek, a herpes simplex virus type 1 (HSV-1) vector-based gene therapy, has been given approval by the FDA for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) who have mutations in the collagen type VII alpha 1 chain (COL7A1) gene. In this FDA approval Patients with DEB must be at least six months old. DEB is a genetic disorder that affects connective tissue and is caused by mutations in the COL7A1 gene. It is divided into two types: RDEB and DDEB, which affect the skin and nails and cause painful blisters and wounds.
Among those who are afflicted, symptoms might differ greatly.
- DDEB: The hands, feet, knees, and elbows are the main areas of blistering in people with DDEB, who normally experience mild forms of the condition.
- RDEB: Cases of RDEB can be excruciatingly painful and incapacitating; they frequently involve extensive blistering that can cause eyesight loss, deformity, and other severe medical problems that could be deadly.
Vyjuvek is a virus that delivers the COL7A1 gene to wounds. COL7 molecules form anchoring fibrils that hold the epidermis and dermis together. Vyjuvek is mixed with a non-active ingredient gel for topical application to wounds. The most frequent side effects of Vyjuvek were itchiness, chills, redness, rash, cough, and runny nose.
When receiving therapy with Vyjuvek, patients or their caregivers should take the following precautions:
- After using Vyjuvek, stay away from touching, rubbing, and itching treated wounds as well as the wound dressings for around 24 hours. Patients and others who have been exposed accidentally should clean the affected area.
- Wash your hands and wear gloves when changing wound dressings.
- Disinfect bandages with virucidal agents and dispose of them with household trash.
Fast Track and Orphan Drug status were given to this application. A Rare Pediatric Disease Priority Review Voucher and the Regenerative Medicine Advanced Therapy and Priority Review designations were also given to Vyjuvek. The FDA’s rare pediatric disease priority review voucher program aims to promote the creation of novel medications and biologics for the prevention and/or treatment of rare pediatric disorders.
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Source: FDA Approves First Topical Gene Therapy
