DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Years-Old

Core Viewpoint - DBV Technologies has confirmed alignment with the U.S. FDA on an Accelerated Approval pathway for the Viaskin Peanut patch aimed at toddlers aged 1 to 3 years, with key study design elements agreed upon for the upcoming COMFORT Toddlers study, set to begin in Q2 2025, and a Biologics License Application (BLA) submission anticipated in the second half of 2026 [2][3][17]. Regulatory Pathway - The FDA has issued written communication confirming an Accelerated Approval pathway for the Viaskin Peanut patch, which must meet three qualifying criteria: treatment of a serious condition, meaningful advantage over existing therapies, and demonstration of an effect likely to predict clinical benefit [4]. - DBV has received confirmation that the Viaskin Peanut patch meets the first two criteria and that the efficacy data from the Phase 3 EPITOPE study can serve as an intermediate clinical endpoint for the third criterion [5][4]. Study Design and Execution - The COMFORT Toddlers study will be a Phase 3 double-blind, placebo-controlled study designed to generate additional safety and adhesion data for the Viaskin Peanut patch in peanut-allergic toddlers [13]. - The study is expected to enroll approximately 480 subjects across 80-90 study centers in the U.S., Canada, Australia, and Europe, with a six-month study duration followed by an optional 18-month open-label treatment phase [14][13]. Product Development - DBV has made modifications to the Viaskin Peanut patch to enhance caregiver application simplicity and product identification, while maintaining the same device components in contact with the patient's skin [6]. - The commercial Viaskin Peanut patch has been used in 304 subjects with over 234,695 patient-days of therapy, showing no clinically relevant differences in efficacy or safety compared to the clinical patch used in the EPITOPE study [10]. Post-Marketing Study - The FDA has confirmed criteria for a post-marketing confirmatory study, which will assess the effectiveness of the intended commercial Viaskin Peanut patch and must be initiated at the time of BLA submission [9]. - The confirmatory study will include a double-blind, placebo-controlled food challenge and will use the same statistical criteria for success as the EPITOPE Phase 3 efficacy study [11]. Company Overview - DBV Technologies is a clinical-stage biopharmaceutical company focused on developing treatment options for food allergies through its proprietary Viaskin patch technology, which aims to modify allergic reactions by re-educating the immune system [19]. - The company is headquartered in Châtillon, France, with North American operations in Warren, NJ, and its shares are traded on Euronext Paris and the Nasdaq Capital Market [20].