DBV Technologies S.A. announced on September 29, 2026, that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the VIASKIN Peanut Patch. The filing specifically targets children aged 4 through 7 years with peanut allergy. The company has requested Priority Review of the application.
The BLA is supported by the results of the Phase 3 VITESSE clinical trial. This study was a global, randomized, double-blind, placebo-controlled trial conducted at 86 sites across the United States, Canada, the United Kingdom, Europe, and Australia. The VITESSE trial enrolled 654 children with peanut allergy, randomized 2:1 to receive either the VIASKIN Peanut Patch or placebo.
The primary endpoint of the VITESSE study was the difference between the percentage of treatment responders in the active versus placebo group after 12 months of treatment. Following the 12-month double-blind period, participants were given the option to continue into an open-label extension where all participants received the patch for up to a total of three years.
The VIASKIN Peanut Patch utilizes epicutaneous immunotherapy (EPIT), a non-invasive approach that delivers small amounts of allergen protein through the skin. The FDA previously granted Breakthrough Therapy Designation to the VIASKIN Peanut Patch. The company is headquartered in Châtillon, France, with North American operations in Warren, New Jersey.
