DBV Technologies has submitted a Biologics License Application to the U.S. Food and Drug Administration for the VIASKIN Peanut Patch in children with peanut allergy aged 4 through 7 years. The company has requested Priority Review of the application, and the FDA previously granted Breakthrough Therapy Designation to the patch. The submission is supported by positive results from the Phase 3 VITESSE trial, which enrolled 654 children and is the largest immunotherapy clinical trial to date for this population. VITESSE was conducted at 86 sites across the United States, Canada, United Kingdom, Europe, and Australia, with participants randomized 2:1 to receive the VIASKIN Peanut Patch or placebo. Chief Executive Officer Daniel Tassé called the submission a significant milestone in DBV's transformation into a commercial organization.
DBV Technologies S.A.DBV submitted a BLA to the FDA for the VIASKIN Peanut Patch and requested Priority Review, a regulatory milestone toward commercialization
Shanghai Henlius Biotech Inc
