On May 19, the U.S. Food and Drug Administration (FDA) approved a novel herpes-simplex virus type 1 vector-based gene therapy, beremagene geperpavec-svdt (Vyjuvek), for the treatment of wounds in patients aged 6 months and older who have dystrophic epidermolysis bullosa with COL7A1 mutations. Deficiencies in the COL7A1 gene result in a loss of skin integrity and lead to the blisters and wounds associated with the disease—as well as more severe adverse effects such as vision loss, disfigurement, and death. Beremagene geperpavec—also known as B-VEC—is designed to target these deficiencies by transporting copies of the COL7A1 gene to the wound sites in order to strengthen the layers of the skin after topical application. In a recent study, researchers randomly applied B-VEC or placebo to two wounds on each of the 31 patients involved in the trial to test the efficacy of the new medication. They found that after 24 weeks of follow-up, 65% of wounds that were treated with B-VEC demonstrated complete wound closure compared with only 26% of those treated with placebo. Patients treated with B-VEC experienced side effects such as redness, itchiness, rashes, chills, coughing, and runny noses. The experts recommended that patients with dystrophic epidermolysis bullosa who receive B-VEC once weekly should avoid touching the treated wound sites for 24 hours after the medication is administered, wear gloves when changing the wound dressings, and use a virucidal agent to disinfect bandages from the initial dressing before disposing of it.
May 25, 2023