CHÂTILLON, France — September 30, 2026
DBV Technologies announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the VIASKIN Peanut Patch in children aged 4 through 7 years with peanut allergy. The company has requested Priority Review for the application, which is supported by results from the Phase 3 VITESSE trial, described by DBV as the largest immunotherapy clinical trial conducted to date in this patient population. The FDA previously granted Breakthrough Therapy Designation to the VIASKIN Peanut Patch. The regulatory submission represents a major step in DBV’s development program for its non-invasive epicutaneous immunotherapy approach to peanut allergy.
VITESSE Supports VIASKIN Peanut Patch BLA
The BLA is supported by the Phase 3 VITESSE trial, which enrolled 654 children aged 4 through 7 years with peanut allergy. The global randomized, double-blind, placebo-controlled study evaluated the 250 µg VIASKIN Peanut Patch with participants randomized 2:1 to active treatment or placebo. Conducted at 86 sites across the United States, Canada, the United Kingdom, Europe and Australia, the trial’s primary endpoint was the difference in the percentage of treatment responders between the active and placebo groups after 12 months. Following the double-blind period, participants could enter an open-label extension in which all children receive the VIASKIN Peanut Patch for up to three years of total treatment. DBV said the positive VITESSE results form the clinical basis for the submitted BLA.
VIASKIN Uses Epicutaneous Immunotherapy
The VIASKIN Peanut Patch uses epicutaneous immunotherapy (EPIT), a non-oral and non-injection approach designed to deliver microgram quantities of peanut allergen through intact skin. The technology is intended to leverage the immune properties of the skin to progressively desensitize children to peanut allergens. Rather than administering allergen orally or through injection, the patch delivers the allergen protein across the skin as part of an approach intended to modify the immune response. DBV is also evaluating the VIASKIN Peanut Patch in other pediatric populations, including toddlers aged 1 through 3 years and children aged 4 through 7 years. The company continues to evaluate the technology through clinical development as it seeks to expand treatment options for food allergy.
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FDA Priority Review Requested for Peanut Allergy Therapy
DBV has requested FDA Priority Review of the BLA, potentially shortening the standard review timeline if the request is granted. The submission follows the company’s continued regulatory engagement with the FDA and the earlier Breakthrough Therapy Designation for the VIASKIN Peanut Patch. The BLA remains under FDA review, and submission does not constitute approval. If authorized, the product would provide a non-invasive immunotherapy option for children with peanut allergy in the targeted age group. DBV said the filing also marks a transition toward becoming a commercial-stage organization as it advances its food allergy portfolio, while the ultimate regulatory decision and labeling will depend on the FDA’s review of the complete application.
Source :DBV Technologies press release
