What Is Vyjuvek, and Why Does It Matter?
Vyjuvek (beremagene geperpavec-svdt) is the first topical gene therapy approved to heal wounds in adults and children with dystrophic epidermolysis bullosa (DEB). DEB is a rare genetic skin condition in which a faulty COL7A1 gene affects the skin’s integrity, making it extremely fragile and prone to painful blisters, open wounds, or scarring, even with minor friction or injury.
A recent FDA label update now allows Vyjuvek to be used from birth. It can also be applied at home by you or a caregiver, offering more flexibility and making treatment more convenient and easier to manage. Dressings can now be changed at the next routine change instead of waiting for the next 24 hours.
Vyjuvek is a gel-based treatment made from a modified virus that delivers working copies of the COL7A1 gene directly to the skin. When applied to wounds, it helps your body make a protein called COL7, which is needed to keep the layers of your skin connected. This can help your skin heal better and stay stronger. Vyjuvek can be used multiple times, unlike most gene therapies that are given only once. This matters for DEB, which causes recurring wounds.
Previously, Vyjuvek was approved only for patients aged 6 months or older, had to be applied by health care professionals, and required waiting 24 hours before changing dressings.
Why Was It Approved?
The FDA approved the updated label for Vyjuvek based on real-world use and ongoing study results. These findings showed that Vyjuvek continues to be safe, well tolerated, and effective for people of all ages, including when it’s applied at home by you or your caregiver.
In a clinical study, the medicine significantly improved wound healing at three and six months compared with a placebo. In a long-term study, patients who continued treatment saw wound closure rates between 61% and 90% over 12 months.
The most common side effects of Vyjuvek gel include itching, chills, redness, rash, cough, and runny nose.
What Do I Need to Know?
Vyjuvek is a liquid medicine that is mixed with a gel at the pharmacy before it can be used. You or your caregiver can apply the prepared gel directly to your wounds once a week at home, depending on your situation. After applying the gel, the wound is covered with a special dressing, and you should avoid touching or scratching the area until the next dressing change. Always wash your hands and wear protective gloves while changing and disposing of wound dressings. If any of the medicine accidentally gets in your eyes or mouth, rinse with clean water for at least 15 minutes.
If you miss a dose, apply it as soon as you can and continue with your regular weekly schedule.
If you are pregnant, you should not prepare or apply Vyjuvek or touch treated wounds or dressings from the treated wounds.
Before starting Vyjuvek gel, let your doctor know about any health conditions you have, including if you’re pregnant, planning to become pregnant, or breastfeeding, as it’s not known if the gel could affect a fetus or pass into breast milk. If you are able to become pregnant, you should use birth control while using this medicine. Also, be sure to inform your health care provider about all the medicines, vitamins, or herbal supplements you’re taking.