VIASKIN Peanut Patch Effective in Peanut-Allergic Children Aged 4–7 Years

The phase 3 VITESSE trial of the VIASKIN® Peanut patch met its primary endpoint in peanut-allergic children aged 4 to 7 years, DBV Technologies announced December 17, 2025. The lower bound of the 95% confidence interval for the difference between treatment arms was 24.5%, exceeding the prespecified threshold of 15%.1

“I’m thrilled by these topline results, which show a statistically significant treatment effect in children treated with the VIASKIN Peanut patch,” said lead investigator David Fleischer, MD, professor of pediatrics at Children's Hospital Colorado, in a statement.1 “The levels of desensitization achieved in this study after one year on treatment are highly clinically meaningful and represent substantial progress towards a well-tolerated, non-invasive potential option that I believe would be welcomed into pediatric care.”

The VITESSE phase 3, randomized, double-blind, placebo-controlled multi-site trial enrolled 654 children, with 438 randomized to VIASKIN Peanut and 216 to placebo. The primary endpoint was the difference between the percentage of treatment responders in the active versus placebo arm after 12 months of treatment.

At 12 months, VIASKIN Peanut demonstrated a statistically significant treatment effect (P <.001), with 46.6% of treated children meeting the responder criteria compared with 14.8% in the placebo arm, corresponding to a 31.8% difference in response rates (95% CI, 24.5–39.0), exceeding the pre-specified lower-bound threshold of 15%.1

The study defined responders as children who increased their eliciting dose, the amount of peanut protein that induced an allergic reaction, from ≤30 mg at baseline to ≥300 mg of peanut protein at 12 months, or from 100 mg at baseline to ≥600 mg at 12 months, as assessed by double-blind, placebo-controlled food challenge (DBPCFC).

“As a practicing allergist, I look forward to what that may mean for families managing peanut allergy every day and hope to be able to implement this treatment in my clinic, if approved,” Fleischer added.1

Safety findings were consistent with previous trials in the VIASKIN Peanut clinical program, with no treatment-related serious adverse events and high compliance (96.2%). The most common treatment-emergent adverse event (TEAE) was mild-to-moderate local skin reactions at the patch application site. TEAE-related discontinuations were low (3.2% in the treatment arm vs 0.5% in the placebo arm).1

“We saw tremendous enthusiasm around EPIT and the VIASKIN Peanut patch development program at ACAAI’s annual scientific meeting last month,” said allergist Cherie Zachary, MD, president of the American College of Allergy, Asthma and Immunology (ACAAI).1 “I am excited to see what’s possible with this innovative treatment in 4-7-year-old patients, if approved. I look forward to open-label results in the future to fully understand the potential impact VIASKIN Peanut can have in this age group.”

At ACAAI 2025, HCPLive covered the late-breaking presentation, “Peanut Patch Treatment Continues to Help Toddlers Safely Build Tolerance Over Three Years,” about the open-label extension of the EPITOBE study. The extension followed 56 toddlers who had received a placebo in the initial 1-year trial and subsequently used the peanut patch for up to 3 years. After 3 years of treatment, 71.2% of toddlers tolerated the equivalent of 3 to 4 peanut kernels (≥1000 mg), compared with 62.7% after 1 year.2

DBV plans to submit a Biologics License Application (BLA) to the US Food & Drug Administration (FDA) in the first half of 2026.1 The company expects the BLA may be eligible for priority review since the FDA had previously granted VIASKIN Peanut patch a Breakthrough Therapy Designation.

“VITESSE is the largest immunotherapy clinical trial ever conducted in food allergy [with 86 sites across the United States, Canada, the United Kingdom, Europe, and Australia], and we are thrilled that the resulting clinical evidence supporting the VIASKIN Peanut patch is robust,” said Daniel Tassé, Chief Executive Officer of DBV Technologies, in a statement.1 “With these data in hand, I am looking forward to submitting the BLA to the FDA, as planned, in the first half of 2026.”

References

1. DBV Technologies Announces Positive Topline Results from Phase 3 VITESSE Trial of VIASKIN® Peanut Patch in Peanut Allergic Children Aged 4-7 Years. Globe Newswire. Published December 16, 2025. Accessed December 17, 2025. https://www.globenewswire.com/news-release/2025/12/16/3206604/0/en/DBV-Technologies-Announces-Positive-Topline-Results-from-Phase-3-VITESSE-Trial-of-VIASKIN-Peanut-Patch-in-Peanut-Allergic-Children-Aged-4-7-Years.html

2. Derman C. Over 70% of Toddlers Tolerate 3 to 4 Peanut Kernels 3 Years After Peanut Patch. HCPLive. Published November 21, 2025. https://www.hcplive.com/view/over-70-toddlers-tolerate-3-to-4-peanut-kernels-3-years-peanut-patch. Accessed December 17, 2025.