DBV Technologies Submits FDA Application for Peanut Allergy Patch
The Châtillon-based biotech company has advanced a regulatory milestone in the United States by submitting to the FDA a license application for its peanut allergy patch intended for children aged 4 to 7 years. The company is requesting priority review of the application.
License Application for Children Aged 4 to 7 Years with Peanut Allergy
DBV Technologies announced the submission to the Food and Drug Administration (FDA) of a Biologics License Application (BLA) for Viaskin Peanut, intended for children aged 4 to 7 years suffering from peanut allergy. The company requested priority review of the application. The patch is based on epicutaneous immunotherapy (EPIT), a non-oral and non-injectable approach that delivers small quantities of allergen protein through the skin, with the aim of progressively desensitizing the child to peanut allergy. The FDA had previously granted the product Breakthrough Therapy designation. According to Daniel Tassé, Chief Executive Officer of DBV Technologies, this submission "marks an important milestone in DBV's transformation into a commercial organization" and brings the patch closer to availability for this pediatric population.
Phase 3 VITESSE Trial Results in Support
The application is supported by the results of the Phase 3 VITESSE clinical trial, conducted in 654 children aged 4 to 7 years, presented by the company as the largest immunotherapy trial conducted to date for this population. It is a randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of the patch (250 µg), with a 2:1 randomization between active treatment and placebo. The study was conducted across 86 sites distributed in the United States, Canada, the United Kingdom, Europe, and Australia. The primary endpoint focuses on the difference in percentage of treatment responders between the active group and the placebo group after twelve months of treatment. Following this double-blind period, children were able to continue in an open-label extension, where all participants receive the patch for a total duration of up to three years of treatment. DBV Technologies is also conducting trials of the patch in very young children (1 to 3 years) and in children aged 4 to 7 years. The company clarifies that at this stage, its candidate products are not authorized for sale in any country.
