DBV Technologies submits BLA to FDA for Viaskin Peanut Patch in children 4-7

DBV Technologies announced on September 29, 2026 that it had submitted a Biologics License Application to the U.S. Food and Drug Administration for the VIASKIN Peanut Patch in children with peanut allergy between the ages of 4 and 7.¹ The company has requested Priority Review of the BLA.¹ The FDA had previously granted Breakthrough Therapy Designation to the VIASKIN Peanut Patch.¹

The filing rests on data from the Phase 3 "VITESSE" study. The BLA is supported by positive results from the VITESSE Phase 3 trial of the VIASKIN Peanut Patch in 654 children ages 4 through 7 with peanut allergy.¹ DBV described VITESSE as the largest immunotherapy clinical trial to date for this population.¹

According to the trial's registry description, VITESSE (NCT05741476) is a global Phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of the 250 microgram VIASKIN Peanut patch in children ages 4-7 with peanut allergy.¹ The 654 enrolled children were randomized 2:1 to receive either the patch or placebo.¹ The study was conducted at 86 sites across the United States, Canada, United Kingdom, Europe, and Australia.¹ Its primary endpoint compared the percentage of treatment responders between the active and placebo arms after 12 months of treatment.¹ After the double-blind period, participants could enter an open-label extension in which everyone receives the patch for up to a total of three years on treatment.¹

The patch uses epicutaneous immunotherapy, which DBV describes as a non-oral, non-injection method that delivers small amounts of an allergen protein through the skin¹ to gradually desensitize patients. DBV noted that its product candidates have not been authorized for sale in any country¹ at this stage.