DBV Technologies has officially submitted a Biologics License Application (BLA) to the US Food and Drug Administration for its investigational VIASKIN® Peanut Patch. The regulatory filing targets young patients aged 4 through 7 years who suffer from peanut allergies, offering potential relief for a demographic with significant unmet medical needs. Alongside the submission, the French biopharmaceutical company requested a Priority Review from the agency to expedite its regulatory evaluation.
The investigational patch had previously earned Breakthrough Therapy Designation from the FDA, a status intended to accelerate the development and review of drugs targeting serious or life-threatening conditions. If approved, the therapy would introduce an innovative, non-invasive alternative to traditional allergy treatments. Rather than relying on oral ingestion or regular injections, the patch administers microgram quantities of peanut protein directly onto intact skin to desensitize the immune system over time.
Executive leadership framed the application as a transformative achievement for both the patient community and the company’s corporate roadmap. “The submission of our BLA brings VIASKIN® Peanut Patch, a non-invasive, practical treatment option, one step closer to being available for children ages 4 through 7 living with peanut allergy, and marks a significant milestone in DBV’s transformation into a commercial organization,” said Daniel Tassé, Chief Executive Officer of DBV Technologies.
Tassé underscored the collaborative effort required to reach this stage of clinical and regulatory maturity. “This BLA reflects years of rigorous clinical development, meaningful contributions from the entire food allergy community, and ongoing collaboration with the FDA,” Tassé added. “We are grateful for the Agency’s constructive engagement over the last few months and look forward to working closely with them during the review process.”
At the core of the submission are positive results from the Phase 3 VITESSE clinical trial, which enrolled 654 peanut-allergic children across 86 trial sites spanning the United States, Canada, the United Kingdom, Europe, and Australia. DBV noted that VITESSE stands as the largest immunotherapy clinical trial conducted to date in this specific age cohort. The randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of a 250 µg dose of the patch versus a placebo over a 12-month double-blind period.
The underlying mechanism driving the therapy is DBV’s proprietary epicutaneous immunotherapy (EPIT) platform. By leveraging the specialized immune-tolerizing properties of the skin, EPIT seeks to re-educate the immune system to tolerate allergens without exposing the broader circulatory or digestive systems to rapid systemic absorption. Following the primary 12-month endpoint evaluation in VITESSE, participants were eligible to join an open-label extension to continue patch therapy for up to three years of total treatment.
Headquartered in Châtillon, France, with North American operations in Warren, New Jersey, DBV Technologies is advancing a pipeline of EPIT-based programs targeting food allergies. Beyond the 4-to-7 age group, the company is conducting clinical evaluations of the VIASKIN® Peanut Patch in toddlers aged 1 through 3 years, as it seeks to expand treatment options for early-childhood food allergies that carry risks ranging from mild discomfort to life-threatening anaphylaxis.
