David Fleischer, MD, says phase 3 VITESSE results show the Viaskin peanut patch offers a safe, practical desensitization option for young children with peanut allergy.
New insights from the pivotal phase 3 VITESSE trial continue to shape the clinical conversation around epicutaneous immunotherapy for peanut allergy, particularly in younger children. In an interview following the
VITESSE enrolled children aged 4 to 7 years with peanut allergy who reacted to 150 mg of peanut protein or less at baseline. After 12 months of treatment with the Viaskin peanut patch, approximately half of the treated patients met the primary efficacy endpoint, demonstrating clinically meaningful desensitization. As Fleischer explained, “about 50% of patients reached that primary endpoint, meaning that they were desensitized by this product, meaning that the amount of peanut they tolerated before the therapy increased after a year of therapy.”
Beyond efficacy, Fleischer emphasized how the patch may address longstanding challenges with existing peanut allergy treatments. Current FDA-approved or commonly used options include oral immunotherapy, which requires daily ingestion of peanut protein and activity restrictions, and injectable biologics such as omalizumab. “You’ve got something that patients don’t want with shots all the time, and something that has more restrictions on your daily activities…that the patch doesn’t have,” he said. The Viaskin patch delivers microgram amounts of peanut protein through intact skin, avoiding ingestion altogether—an important distinction for families reluctant to have children consume the allergen.
Regulatory plans are progressing in parallel with additional clinical development. Fleischer noted that DBV Technologies is expected to pursue approval for children aged 4 to 7 years first, with expansion to younger patients dependent on results from the ongoing COMFORT safety study in children aged 1 to 3 years. “The ultimate goal is to get to 1- to 7-year-olds. We’re closer,” he said, describing the program as the result of a two-decade development effort.
From a practical standpoint, Fleischer underscored the importance of early referral and collaboration between primary care clinicians and allergy specialists. “The earlier you refer, and the earlier you do these interventions, the therapies work better the younger you are,” he said, noting that outcomes consistently favor younger children. Because food allergy therapies require supervised challenges and longitudinal decision-making, he stressed that these treatments are best managed in partnership with specialists rather than solely in primary care settings.
If approved, the Viaskin peanut patch could offer a noninvasive, well-tolerated option that aligns with the needs of young children and families—an approach many in pediatric allergy have been awaiting. According to DBV Technologies, these new data were consistent with prior safety studies, keeping a potential biologics license application submission on track for the first half of 2026.
Reference:
Ebert M. Phase 3 trial meets primary endpoint for Viaskin peanut patch in children aged 4 to 7 years. Contemporary Pediatrics. Published December 17, 2025. Accessed January 6, 2026. https://www.contemporarypediatrics.com/view/phase-3-trial-meets-primary-endpoint-for-viaskin-peanut-patch-in-children-aged-4-7-years
