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DBV Technologies submits BLA to FDA for VIASKIN Peanut Patch, seeking Priority Review
DBVTDBV Technologies S.A.
DBV Technologies S.A. submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for VIASKIN Peanut Patch, an epicutaneous immunotherapy treatment for peanut allergy in children aged 4 through 7 years. The submission is supported by positive results from the VITESSE Phase 3 clinical trial, which enrolled 654 children across 86 sites globally. DBV has requested Priority Review and previously received Breakthrough Therapy Designation for the product. This regulatory milestone marks a significant step toward commercialization for the late-stage biopharmaceutical company.