DBV Technologies submits FDA application for VIASKIN Peanut Patch in children aged 4-7

  • DBV Technologies submitted a BLA to the FDA for VIASKIN Peanut Patch.
  • 654 children aged 4-7 participated in the Phase 3 VITESSE trial.
  • DBV requested Priority Review; FDA previously granted Breakthrough Therapy Designation.

DBV Technologies submitted a Biologics License Application to the U.S. Food and Drug Administration for the VIASKIN Peanut Patch in children aged 4 through 7 with peanut allergy and requested Priority Review. The filing is supported by positive results from the Phase 3 VITESSE trial, which enrolled 654 children and is the largest immunotherapy study reported for this population. The patch uses epicutaneous immunotherapy (EPIT), delivering small amounts of peanut allergen through intact skin in a non-oral, non-injection approach designed to progressively desensitize patients. The FDA previously granted the product Breakthrough Therapy Designation. The filing does not mean the product has been approved, and DBV said its candidates have not been authorized for sale in any country.

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