The FDA has approved Zevaskyn, the first gene-modified cellular therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosis, a rare genetic skin disorder.
Made by Abeona Therapeutics, Zevaskyn consists of gene-corrected skin grafts made from the patients’ own cells, according to an April 29 news release from the company. The therapy is approved for both adult and pediatric patients and is the first FDA-approved treatment for the condition’s wounds using a single application.
The approval is based on results from a phase 3 trial, which showed 81% of large wounds treated with Zevaskyn experienced at least 50% healing at six months, compared to 16% in match wounds treated with standard care.
Earlier studies also indicated that a single application of Zevaskyn led to long-term improvement with some benefits lasting about seven years, the release said.
