Beremagene geperpavec
Contents
Description
Beremagene geperpavec is a topical gene therapy for the treatment of wounds in patients with dystrophic epidermolysis bullosa with mutation(s) in the COL7A1 gene. It is a replication-incompetent, non-integrating herpes simplex virus type 1 (HSV-1)-based vector expressing two copies of the human COL7A1 gene encoding type VII collagen. This first-in-class gene therapy was approved by the FDA in May 2023 for the treatment of wounds in patients six months of age and older with dystrophic epidermolysis bullosa.
Indications & Therapeutic Use
Dystrophic epidermolysis bullosa, junctional epidermolysis bullosa (investigational)
Linked Diseases:
Global Availability (1 countries)
| Country | Access Route | Regulatory Pathway | Lead Time | Status |
|---|---|---|---|---|
| — | — | — | — |
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| Generic Name | Beremagene geperpavec |
| Brands | 1 brand available |
| Active Ingredient | Beremagene geperpavec |
| Drug Class | Dystrophic epidermolysis bullosa |
| Manufacturer | Krystal Biotech |
| Dosage Forms | Topical gel, 1×10^7 PFU/cm² |
| Medical Code | D11AX |
| Orphan Status | Yes — Orphan Drug |
| Cold Chain | Required |
| Lead Time | 14 days |
| Reg. Status | FDA Approved |
| Clinical Trial | NCT04491604 |
| Countries | 1 countries |