DBV Technologies submits BLA to FDA for VIASKIN Peanut Patch in children aged 4-7, requests Priority Review

DBV Technologies S.A.

BLA submitted September 29, 2026 for the VIASKIN Peanut Patch (250 µg) in children aged 4 through 7 years with peanut allergy; DBV requested Priority Review.
Application is supported by the Phase 3 VITESSE trial in 654 children, randomized 2:1, conducted at 86 sites across the US, Canada, UK, Europe and Australia.
Primary endpoint: difference in responder rate between active and placebo groups after 12 months; patients could continue into an open-label extension for up to three years.
FDA previously granted Breakthrough Therapy Designation to the VIASKIN Peanut Patch; CEO Daniel Tassé called the submission a milestone in DBV's transformation into a commercial organization.
VIASKIN uses epicutaneous immunotherapy (EPIT), a non-oral, non-injection approach designed to progressively desensitize children to peanut allergy.

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