The USFDA has approved beremagene-geperpavec-svdt for treating wounds in patients with dystrophic epidermolysis bullosa (DEB). It is a herpes-simplex virus type 1 (HSV-1) vector-based redosable gene therapy to be directly applied to the wounds to deliver two copies of the COL7A1 gene. The approval was based on the safety and efficacy outcomes of beremagene-geperpavec-svdt in two clinical trials.
Data from GEM-1/2 and GEM-3 trial Repeat beremagene-geperpavec-svdt application showed durable wound closure and full-length cutaneous COL7 expression with minimal adverse events in the GEM-1/2 trial. In the GEM-3 trial, beremagene-geperpavec-svdt demonstrated complete wound healing at three and six months without any drug-related serious adverse events. Indication For the treatment of wounds in DEB patients ≥ six months with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene…
