Vyjuvek (beremagene geperpavec-svdt)
An approved treatment for Epidermolysis Bullosa.
The same compound appears under different names depending on the context. Here is how to identify Beremagene geperpavec-svdt wherever you encounter it, plus the key facts at a glance.
- Generic name
- Beremagene geperpavec-svdt
- Brand name
- Vyjuvek
- Development codes
- B-VEC, KB103
- Drug class
- HSV-1 vector-based topical gene therapy
- Manufacturer
- Krystal Biotech
- How it's taken
- Vyjuvek is mixed at the pharmacy from a vial of the gene therapy and a vial of gel, then applied to wounds once a week as small drops spaced about 1 cm apart (the width of a fingertip) in a grid pattern.
A gene therapy gel dripped onto open wounds once a week, approved by the FDA on May 19, 2023 for wounds in people with dystrophic epidermolysis bullosa (DEB) caused by changes in the COL7A1 gene. A September 12, 2025 label update extended use to babies from birth and allowed patients and caregivers to apply it at home. In its main trial, 65% of treated wounds had closed completely at about 6 months, against 26% of matched wounds treated with a placebo gel.
Where Beremagene geperpavec-svdt fits
The first of 3 wound treatments the FDA has approved for EB, and the only one that is a gene therapy applied each week at home or in a clinic. Filsuvez (birch triterpenes) gel followed in December 2023 and Zevaskyn (gene-corrected skin cell sheets) in April 2025.
How Beremagene geperpavec-svdt works
In dystrophic EB, changes in the COL7A1 gene mean the skin makes too little working type VII collagen, the protein that forms anchoring fibrils, tiny fibers that hold the top layer of skin (the epidermis) to the layer underneath (the dermis). Vyjuvek is a herpes simplex virus type 1 that has been altered so it cannot copy itself, and it carries working copies of the human COL7A1 gene. When the gel is dripped onto a wound, the virus enters skin cells called keratinocytes and fibroblasts and delivers the gene to the cell nucleus, where the cells start making type VII collagen that assembles into anchoring fibrils. The virus does not insert itself into the patient's own DNA, so the gel is reapplied each week to wounds until they close.
Mechanism: Topical gene therapy that uses a disabled herpes simplex virus type 1 (HSV-1) vector to deliver working copies of the COL7A1 gene to skin cells in dystrophic EB wounds so they can make type VII collagen
Side effects and safety
- Accidental exposure of others. Avoid touching or scratching treated wounds and their dressings until the next dressing change. Wear protective gloves when changing dressings, and flush the eyes or mouth with clean water for at least 15 minutes after a splash.
- Pregnancy. People who are pregnant should not prepare or apply the gel and should avoid direct contact with treated wounds or their dressings.
- Dressing disposal. Disinfect bandages from the first dressing change after treatment with a virucidal agent such as 70% isopropyl alcohol, seal them in a separate plastic bag and put them in household trash.
- No routine lab monitoring is listed in the label
- Keep track of which wounds have been treated, since the label gives priority to previously treated wounds that re-open
Vyjuvek has no boxed warning and no contraindications. In the main trial of 31 patients, the most common side effects were itching (10%), chills (10%), redness (6%), rash (6%), cough (6%) and runny nose (6%), and no one stopped treatment because of side effects. Because each patient had both a Vyjuvek-treated wound and a placebo-treated wound, the label does not give separate placebo rates. The label's one warning is about accidental exposure: the gel contains a live but disabled virus, so family members and caregivers should avoid touching treated wounds and dressings until the next dressing change, wear gloves when changing dressings, and flush the eyes with clean water for at least 15 minutes after a splash. People who are pregnant should not prepare or apply the gel and should avoid contact with treated wounds and their dressings[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Beremagene geperpavec-svdt
Vyjuvek is mixed at the pharmacy from a vial of the gene therapy and a vial of gel, then applied to wounds once a week as small drops spaced about 1 cm apart (the width of a fingertip) in a grid pattern. The drops are covered with a hydrophobic (water-repelling) dressing and then the patient's usual dressing, which stays on until the next dressing change. The maximum weekly dose is 2 billion PFU (plaque-forming units, a measure of active virus) in 1 mL of gel for children under 3, and 4 billion PFU in 2 mL for everyone 3 and older, with the amount per wound based on wound size. It may not be possible to treat every wound each week, so wounds are treated until they close before new ones are chosen, and previously treated wounds that re-open get priority. A healthcare professional, the patient or a caregiver can apply it in a clinic or at home. Prepared syringes can stay at room temperature for up to 8 hours, or for up to 48 hours kept cold at 2 to 8°C. A missed dose should be applied as soon as possible, then weekly after that[1].
Availability and cost
Only available as the brand-name product.
Help paying for Vyjuvek
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
VYJUVEK Copay Program: eligible commercially insured patients may pay as little as $0 per prescription, up to $15,000 per calendar year. Not available to cash-paying patients or anyone in Medicare, Medicaid, Medigap, VA, DoD, TRICARE or other government programs. Patients must be US citizens or residents for at least 6 months, and the patient or guardian must be 18 or older to enroll.
For: private insurance · source - Free medicine program
VYJUVEK Patient Assistance Program may provide Vyjuvek at no cost to patients who are uninsured or functionally uninsured and show qualifying financial need.
For: no insurance, underinsured · source - Bridge or quick-start supply
VYJUVEK Quick Start Program may provide a temporary supply at no cost to eligible patients while insurance approval is in process.
The official page does not say who qualifies. Ask the program. · source - Insurance and case manager help
A Patient Access Liaison, Clinical Nurse Educator and Care Coordinator help with benefits investigation, the insurance approval process, finding a treating doctor, and training on application, cleansing and dressings.
The official page does not say who qualifies. Ask the program. · source
Good to know: Phone is 1-844-5-KRYSTAL. Full terms are in a PDF linked from the page (krystalconnect.com/pdf/us_terms.pdf), which was not opened.
- From a charity · The Assistance FundEpidermolysis Bullosa (EB) fundOpen
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
The foundation says: “OPEN — Accepting New Patients. TAF is currently accepting new patient enrollments for this program.”
Access and eligibility
Approved for wounds in adults and children, from birth, with dystrophic epidermolysis bullosa, dominant or recessive, caused by one or more changes in the COL7A1 gene. The main trial required genetic confirmation of a COL7A1 change and included patients aged 1 to 44 years. People who are pregnant should not prepare or apply the gel.
Source: Krystal Connect (Vyjuvek support)
Access program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.
Clinical trial results
Approval rested on GEM-3 (NCT04491604), a Phase 3 trial in 31 people with DEB aged 1 to 44 years, 30 with the recessive form and 1 with the dominant form. In each patient, 2 similar wounds were randomly assigned to weekly Vyjuvek or placebo gel for 26 weeks. Complete wound closure, confirmed at 2 visits 2 weeks apart, occurred in 65% of Vyjuvek-treated wounds at about 6 months against 26% of placebo-treated wounds, and in 68% against 23% at about 3 months[1][9]. The trial was published in the New England Journal of Medicine in December 2022[8]. The 2025 label update drew on real-world data collected since launch and an open-label extension study[7].
Development history
Krystal Biotech developed beremagene geperpavec under the names B-VEC and KB103. The FDA granted orphan drug designation in November 2017 and Regenerative Medicine Advanced Therapy (RMAT) designation in June 2019, and gave the application priority review in August 2022[5]. The FDA approved Vyjuvek on May 19, 2023 for DEB wounds in patients 6 months and older[3]. According to the FDA, treatment for recessive DEB before May 2023 was limited to supportive care such as wound care, avoiding injury and skin cancer screening[6]. On September 12, 2025 the FDA expanded the label to include patients from birth and to allow a healthcare professional, patient or caregiver to apply it at home[4][7].
Explore Epidermolysis Bullosa trials
Other Epidermolysis Bullosa treatments
EB has 3 FDA-approved wound treatments: Vyjuvek (beremagene geperpavec) since May 2023 for dystrophic EB, Filsuvez (birch triterpenes) gel since December 2023 for dystrophic and junctional EB wounds in people 6 months and older, and Zevaskyn (prademagene zamikeracel) since April 2025 for recessive dystrophic EB wounds. No trial has compared them with each other, and none is approved for EB simplex.
Common questions about Beremagene geperpavec-svdt
▸What is Beremagene geperpavec-svdt (Vyjuvek)?
A gene therapy gel dripped onto open wounds once a week, approved by the FDA on May 19, 2023 for wounds in people with dystrophic epidermolysis bullosa (DEB) caused by changes in the COL7A1 gene. A September 12, 2025 label update extended use to babies from birth and allowed patients and caregivers to apply it at home. In its main trial, 65% of treated wounds had closed completely at about 6 months, against 26% of matched wounds treated with a placebo gel.
▸How does Beremagene geperpavec-svdt work?
In dystrophic EB, changes in the COL7A1 gene mean the skin makes too little working type VII collagen, the protein that forms anchoring fibrils, tiny fibers that hold the top layer of skin (the epidermis) to the layer underneath (the dermis). Vyjuvek is a herpes simplex virus type 1 that has been altered so it cannot copy itself, and it carries working copies of the human COL7A1 gene. When the gel is dripped onto a wound, the virus enters skin cells called keratinocytes and fibroblasts and delivers the gene to the cell nucleus, where the cells start making type VII collagen that assembles into anchoring fibrils. The virus does not insert itself into the patient's own DNA, so the gel is reapplied each week to wounds until they close.
▸What are the side effects of Beremagene geperpavec-svdt?
Vyjuvek has no boxed warning and no contraindications. In the main trial of 31 patients, the most common side effects were itching (10%), chills (10%), redness (6%), rash (6%), cough (6%) and runny nose (6%), and no one stopped treatment because of side effects. Because each patient had both a Vyjuvek-treated wound and a placebo-treated wound, the label does not give separate placebo rates. The label's one warning is about accidental exposure: the gel contains a live but disabled virus, so family members and caregivers should avoid touching treated wounds and dressings until the next dressing change, wear gloves when changing dressings, and flush the eyes with clean water for at least 15 minutes after a splash. People who are pregnant should not prepare or apply the gel and should avoid contact with treated wounds and their dressings[1].
▸How is Beremagene geperpavec-svdt taken?
Vyjuvek is mixed at the pharmacy from a vial of the gene therapy and a vial of gel, then applied to wounds once a week as small drops spaced about 1 cm apart (the width of a fingertip) in a grid pattern. The drops are covered with a hydrophobic (water-repelling) dressing and then the patient's usual dressing, which stays on until the next dressing change. The maximum weekly dose is 2 billion PFU (plaque-forming units, a measure of active virus) in 1 mL of gel for children under 3, and 4 billion PFU in 2 mL for everyone 3 and older, with the amount per wound based on wound size. It may not be possible to treat every wound each week, so wounds are treated until they close before new ones are chosen, and previously treated wounds that re-open get priority. A healthcare professional, the patient or a caregiver can apply it in a clinic or at home. Prepared syringes can stay at room temperature for up to 8 hours, or for up to 48 hours kept cold at 2 to 8°C. A missed dose should be applied as soon as possible, then weekly after that[1].
▸Is Beremagene geperpavec-svdt FDA approved?
Yes, Beremagene geperpavec-svdt (Vyjuvek) is FDA approved (2023) for the treatment of Epidermolysis Bullosa.
▸Can Vyjuvek be used on newborns?
Yes. Since a September 12, 2025 label update, Vyjuvek is approved for wounds in people with dystrophic EB from birth. Children under 3 can receive up to 2 billion PFU (1 mL of gel) a week, and people 3 and older up to 4 billion PFU (2 mL). Before that update, the approval started at 6 months of age.
▸Can Vyjuvek be applied at home?
Yes. The same 2025 update allows a healthcare professional, the patient or a caregiver to apply Vyjuvek at home or in a clinic. The pharmacy mixes the gel and supplies ready-to-use syringes. Anyone who is pregnant should not prepare or apply it, and family members should wear gloves when changing dressings and avoid touching treated wounds until the next dressing change.
▸How well does Vyjuvek work for dystrophic EB wounds?
In the GEM-3 trial of 31 patients, 65% of wounds treated weekly with Vyjuvek had closed completely at about 6 months, against 26% of matched wounds treated with placebo gel. At about 3 months the figures were 68% and 23%. Treatment continues weekly, and the label says previously treated wounds that re-open should get priority.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. Food and Drug Administration · 2025-09. VYJUVEK (beremagene geperpavec-svdt) biological suspension mixed with excipient gel for topical application: prescribing information. https://www.fda.gov/media/168350/download
- U.S. Food and Drug Administration, CBER. VYJUVEK (STN 125774). https://www.fda.gov/vaccines-blood-biologics/vyjuvek
- U.S. Food and Drug Administration · 2023-05-19. BLA 125774 approval letter. https://www.fda.gov/media/168356/download
- U.S. Food and Drug Administration · 2025-09-12. BLA 125774/89 supplement approval letter. https://www.fda.gov/media/188709/download
- U.S. Food and Drug Administration · 2023. Summary Basis for Regulatory Action: VYJUVEK. https://www.fda.gov/media/169342/download
- U.S. Food and Drug Administration · 2025-04-28. Summary Basis for Regulatory Action: ZEVASKYN. https://www.fda.gov/media/186796/download
- Krystal Biotech · 2025-09-15. Krystal Biotech Announces FDA Approval of Updated VYJUVEK Label. https://ir.krystalbio.com/news-releases/news-release-details/krystal-biotech-announces-fda-approval-updated-vyjuvekr-label
- New England Journal of Medicine · 2022-12-15. Trial of Beremagene Geperpavec (B-VEC) for Dystrophic Epidermolysis Bullosa. https://pubmed.ncbi.nlm.nih.gov/36516090/
- ClinicalTrials.gov. Ph 3 Efficacy and Safety of B-VEC for the Treatment of DEB (GEM-3). https://clinicaltrials.gov/study/NCT04491604
- Krystal Biotech. About Krystal Connect. https://www.vyjuvek.com/about-krystal-connect/