DBV Technologies Files BLA for VIASKIN Peanut Patch in Young Children, Seeks Priority Review

DBV Technologies (DBVT) said it submitted a Biologics License Application to the U.S. FDA for its VIASKIN Peanut Patch for children aged 4 to 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 — the largest immunotherapy study in this patient population to date. The FDA previously granted Breakthrough Therapy Designation to the patch. VIASKIN uses epicutaneous immunotherapy (EPIT), a non-oral, non-injection approach that delivers small amounts of peanut protein through the skin to desensitize children with peanut allergy. DBVT shares closed at $11.55 on Tuesday, down 0.77%. In overnight trading, the stock rose 1.82% to $11.76.