FOR US RESIDENTS ONLY
NOW APPROVED For the treatment of Dystrophic Epidermolysis Bullosa (DEB) in patients 6 months and older

About VYJUVEK

How it works

See how VYJUVEK treats the genetic cause of dystrophic epidermolysis bullosa (DEB)

VYJUVEK is a topical therapy that delivers new COL7A1 genes directly to DEB skin wounds to promote wound healing.

VYJUVEK™ Patient Story - Emily
“I learned that VYJUVEK basically reintroduces a gene called COL7A1 into my wounds to help my body make the collagen VII protein.” - Emily, living with DEB

Here’s how
VYJUVEK works

VYJUVEK™ delivers new COL7A1 genes directly to skin cells in DEB wounds.
  • VYJUVEK delivers new COL7A1 genes directly to skin cells in DEB wounds
These COL7A1 genes restore the ability of those cells to make working type 7 collagen protein and form anchoring fibrils.
  • These COL7A1 genes restore the ability of those cells to make functional type VII collagen protein and form anchoring fibrils
Anchoring fibrils bind the inner skin layer (dermis) and outer skin layer (epidermis) together and promote wound healing.
  • Anchoring fibrils bind the inner skin layer (dermis) and outer skin layer (epidermis) together and promote wound healing
How VYJUVEK was studied

Wound healing with VYJUVEK was assessed in a clinical study (GEM-3 study) of patients with DEB

The goal of the study was to evaluate complete wound healing (100% closure).

  • The study included 31 people ranging in age from 1 to 44 years old with dominant DEB or recessive DEB
  • For each person, 2 similar wounds were chosen. One was treated with VYJUVEK and the other received placebo
    • Placebo is a treatment containing no medication that was given to participants the same way as VYJUVEK
  • The main measure of the study was complete wound healing at 6 months
  • Treatments were applied weekly until wounds were completely healed. Treatment resumed if wound reopened
  • After completion of the GEM-3 study, patients were allowed to enroll in the Open Label Extension study*
VYJUVEK™ start of the clinical study
Treatments applied weekly for 6 months or until wound was healed
VYJUVEK™ study - early look at complete wound healing
Treatments applied weekly until
wound was healed
VYJUVEK™ study after 6 months

*The Open Label Extension study was designed to assess long-term safety.

Wound Healing Results

VYJUVEK achieved significantly greater complete wound healing (100% closure) compared with placebo

Complete wound healing in 31 patients at 3 and 6 months
Complete wound healing in 31
patients at 3 months
  • 68% of wounds treated with VYJUVEK healed completely vs 23% of wounds treated with placebo
Complete wound healing in 31
patients at 6 months
  • 65% of wounds treated with VYJUVEK healed completely vs 26% of wounds treated with placebo
Complete wound healing in 31 patients at 3 and 6 months

Of the wounds treated with VYJUVEK that were healed at 3 months, 67% (14/21) were also healed at 6 months.†

Wounds healed at 3 months also
healed at 6 months Wounds healed at 3 months and 6 months Wounds healed at 3 months and 6 months

†Data on file.

  • In an analysis done after the study was completed, wounds that were completely healed at 3 months were then reevaluated at 6 months to see what percentage were completely healed
  • These analyses were conducted after the study was completed in an unplanned exploratory analysis of both VYJUVEK-treated and placebo-treated wounds. These findings are based on a limited sample size and should be interpreted carefully
Before and After Images

Before and after treatment with VYJUVEK—in small, medium, and large wounds

See how DEB wounds healed with VYJUVEK

Patient A Small Wound

Lower Abdomen, Pediatric Female

Abdomen of a VYJUVEK™ patient before treatment Abdomen of a VYJUVEK™ patient after treatment
Patient B Medium Wound

Knee, Pediatric Male

Knee of a VYJUVEK™ patient before treatment Knee of a VYJUVEK™ patient after treatment
Patient C Medium Wound

Shoulder Blade, Adult Female

Shoulder blade of a VYJUVEK™ patient before treatment Shoulder blade of a VYJUVEK™ patient after treatment
Patient D Large Wound

Back, Adult Male

Complete wound closure was achieved 2 months into the Open Label Extension study following completion of the GEM-3 study.‡

‡The Open Label Extension study was designed to assess long-term safety.

A wound on back of a VYJUVEK™ patient before treatment A wound on back of a VYJUVEK™ patient after 6 months of treatment A wound on back of a VYJUVEK™ patient after 8 months of treatment
Across small, medium, and large wounds, VYJUVEK achieved complete wound closure.

Interested in learning more about VYJUVEK? First, talk to your doctor.
Use this guide to help you get started.

Download the Doctor Discussion Guide
Safety

VYJUVEK was well tolerated by study participants

Most common side effects in 31 people treated with VYJUVEK
Side effects Number of people (%)
Itching 3 (10)
Chills 3 (10)
Redness 2 (6)
Rash 2 (6)
Cough 2 (6)
Runny Nose 2 (6)
No study participants stopped treatment with VYJUVEK due to side effects.
Hear Patient Stories
INDICATION AND USAGE

VYJUVEK is a topical gel used to treat wounds in patients 6 months and older with dystrophic epidermolysis bullosa (DEB).

IMPORTANT SAFETY INFORMATION

VYJUVEK gel must be applied by a healthcare provider.

After treatment, patients and caregivers should be careful not to touch treated wounds and dressings for 24 hours. If accidentally exposed to the VYJUVEK gel, clean the affected area.

Wash hands and wear protective gloves when changing wound dressings. Disinfect bandages from the first dressing change with a virucidal agent, and dispose of the disinfected bandages in a separate sealed plastic bag in household waste. Dispose of the subsequent used dressings in a sealed plastic bag in household waste.

Patients should avoid touching or scratching wound sites or wound dressings.

The most common adverse reactions (>5%) were itching, chills, redness, rash, cough, and runny nose. These are not all the possible side effects with VYJUVEK. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or to the Sponsor at 1-844-557-9782.

  • Please see Important Safety Information above and click here for full Prescribing Information.
IMPORTANT SAFETY INFORMATION
INDICATION AND USAGE

VYJUVEK is a topical gel used to treat wounds in patients 6 months and older with dystrophic epidermolysis bullosa (DEB).

IMPORTANT SAFETY INFORMATION

VYJUVEK gel must be applied by a healthcare provider.

After treatment, patients and caregivers should be careful not to touch treated wounds and dressings for 24 hours. If accidentally exposed to the VYJUVEK gel, clean the affected area.

Wash hands and wear protective gloves when changing wound dressings. Disinfect bandages from the first dressing change with a virucidal agent, and dispose of the disinfected bandages in a separate sealed plastic bag in household waste. Dispose of the subsequent used dressings in a sealed plastic bag in household waste.

Patients should avoid touching or scratching wound sites or wound dressings.

The most common adverse reactions (>5%) were itching, chills, redness, rash, cough, and runny nose. These are not all the possible side effects with VYJUVEK. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or to the Sponsor at 1-844-557-9782.

  • Please see Important Safety Information above and click here for full Prescribing Information.