DBV Technologies Submits Application for VIASKIN® Peanut Patch to U.S. FDA

DBV Technologies has announced the submission of its Biologics License Application (BLA) to the U.S. FDA for the VIASKIN® Peanut Patch designed for children aged 4 to 7 with peanut allergies. Supported by a successful Phase 3 VITESSE trial, the application seeks Priority Review from the FDA. This trial, involving 654 children, is one of the largest immunotherapy studies for this demographic.

The VIASKIN® Patch utilizes epicutaneous immunotherapy, a non-invasive approach that delivers allergen protein through the skin to progressively desensitize children. The Breakthrough Therapy Designation was previously granted by the FDA, indicating potential improvement over existing therapies.

DBV Technologies, a biopharmaceutical firm based in Châtillon, France, advances its goal of transforming into a commercial entity with this submission. The company emphasizes a collaborative approach with the FDA and acknowledges the support from the food allergy community.