DBV Submits FDA Application for Peanut Allergy Patch in Young Children

DBV Technologies has submitted a Biologics License Application to the FDA for its VIASKIN Peanut Patch, intended for children ages 4 to 7 with peanut allergies, and requested Priority Review. The skin patch uses epicutaneous immunotherapy to deliver small amounts of peanut protein with the aim of gradually desensitizing children. The application is supported by the Phase 3 VITESSE trial, which enrolled 654 children and, according to the company, met its primary endpoint with a statistically significant improvement over placebo. The FDA previously granted the treatment Breakthrough Therapy designation; the application is now under regulatory review.