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Efficacy & Safety Data

Efficacy Data

VYJUVEK demonstrated a significantly higher percentage of complete wound healing* (100% closure) compared with placebo1

Primary endpoint: primary wounds with complete wound healing* (100% closure) at 6 months (N=31).1

Primary endpoint: primary wounds with complete wound healing (100% closure)* at 6 months (N=31)

Key secondary endpoint: primary wounds with complete wound healing* (100% closure) at 3 months (N=31).1

Key secondary endpoint: primary wounds with complete wound healing (100% closure)* at 3 months (N=31)

*Complete (100%) wound closure was defined as durable wound closure (skin re-epithelialization without drainage) evaluated at two consecutive visits two weeks apart.1,2

†Primary endpoint: (95% CI: 14, 63) P=0.012.

‡Secondary endpoint: (95% CI: 22, 69) P=0.003.

Of the wounds treated with VYJUVEK that were closed§ at
3 months, 67% (14/21) were also closed at 6 months.2


In a post-hoc analysis,|| wounds that were closed at 3 months—either VYJUVEK- or placebo-treated—were then re-evaluated at 6 months to determine what percentage of these wounds were closed.

These data are from a post-hoc exploratory analysis of both VYJUVEK-treated and placebo-treated wounds. The findings are based on a limited sample size and should be interpreted carefully.

Wounds closed at 3 months also closed at 6 months.

Wounds closed at 3 months also closed at 6 months

§Complete (100%) wound closure was defined as durable wound closure (skin re-epithelialization without drainage) evaluated at two consecutive visits two weeks apart.1,2

||Data on file.

BEFORE & AFTER IMAGES

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

  • Across small, medium, and large wounds, VYJUVEK achieved complete wound closure
Patient A: Small Wound2

Pediatric female, lower abdomen

Lower abdomen wound before VYJUVEK™ treatment Lower abdomen wound after VYJUVEK™ treatment
Patient B: Medium Wound2

Pediatric male, knee

Knee wound before VYJUVEK™ treatment Knee wound after VYJUVEK™ treatment
Patient C: Medium Wound2

Adult female, lower shoulder blade

Lower shoulder blade wound before VYJUVEK™ treatment Lower shoulder blade wound after VYJUVEK™ treatment
Patient D: Large Wound3

Adult male, back

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

The Open Label Extension trial was designed to assess long-term safety. Evaluation of this wound's complete wound closure was based on same method in GEM-3.

Back wound before VYJUVEK™ treatment Back wound after 6 months of VYJUVEK™ treatment Back wound after 8 months of VYJUVEK™ treatment
Across small, medium, and large wounds, VYJUVEK achieved complete wound closure.

Hear about a patient's experience with VYJUVEK.

See Patient Video
Safety data

VYJUVEK was well tolerated by patients1

  • No discontinuation due to adverse reactions occurred
Most Common Adverse Reactions
(>5%)		 Patients, n (%)
(N=31)
Itching 3 (10)
Chills 3 (10)
Redness 2 (6)
Rash 2 (6)
Cough 2 (6)
Runny nose 2 (6)

See how to use VYJUVEK

Dosing & Administration
INDICATION AND USAGE

VYJUVEK is a topical gel indicated for the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII (COL7A1) gene.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Accidental Exposure to VYJUVEK gel: VYJUVEK will not replicate in the subject’s cells and does not integrate into the subject cells’ native genetic material. For precautions, avoid direct contact with treated wounds (e.g., touching or scratching) and dressings of treated wounds for approximately 24 hours following treatment. Wear protective gloves when assisting subjects with changing wound dressings and handling the disposal. In the event of accidental exposure (e.g., through a splash to the eyes or mucous membranes), flush with clean water for at least 15 minutes.

Clean all surfaces that may have come in contact with VYJUVEK biological suspension or gel and treat all spills with a virucidal agent.

Dispose all materials (e.g., vial, syringe, needle, cleaning materials) that may have come in contact with VYJUVEK biological suspension or gel into a biohazard bag or container.

ADVERSE REACTIONS

The most common adverse reactions (>5%) were itching, chills, redness, rash, cough, and runny nose.


References

1. VYJUVEK [prescribing information]. Krystal Biotech, Inc.; 2023.

2. Marinkovich MP, Gonzalez ME, Guide S, et al. GEM-3: a phase 3 study of beremagene geperpavec (B-VEC), an investigational, topical gene therapy, for the treatment of dystrophic epidermolysis bullosa (DEB). Presented at 2022 AAD Annual Meeting; March 27, 2022; Boston, MA.

3. Data on file.

IMPORTANT SAFETY INFORMATION
INDICATION AND USAGE

VYJUVEK is a topical gel indicated for the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII (COL7A1) gene.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Accidental Exposure to VYJUVEK gel: VYJUVEK will not replicate in the subject’s cells and does not integrate into the subject cells’ native genetic material. For precautions, avoid direct contact with treated wounds (e.g., touching or scratching) and dressings of treated wounds for approximately 24 hours following treatment. Wear protective gloves when assisting subjects with changing wound dressings and handling the disposal. In the event of accidental exposure (e.g., through a splash to the eyes or mucous membranes), flush with clean water for at least 15 minutes.

Clean all surfaces that may have come in contact with VYJUVEK biological suspension or gel and treat all spills with a virucidal agent.

Dispose all materials (e.g., vial, syringe, needle, cleaning materials) that may have come in contact with VYJUVEK biological suspension or gel into a biohazard bag or container.

ADVERSE REACTIONS

The most common adverse reactions (>5%) were itching, chills, redness, rash, cough, and runny nose.


References

1. VYJUVEK [prescribing information]. Krystal Biotech, Inc.; 2023.

2. Marinkovich MP, Gonzalez ME, Guide S, et al. GEM-3: a phase 3 study of beremagene geperpavec (B-VEC), an investigational, topical gene therapy, for the treatment of dystrophic epidermolysis bullosa (DEB). Presented at 2022 AAD Annual Meeting; March 27, 2022; Boston, MA.

3. Data on file.