Late-stage biopharmaceutical company DBV Technologies (Euronext:DBV) (Nasdaq:DBVT) announced on Wednesday that it has submitted a Biologics License Application to the US Food and Drug Administration (FDA) and requested Priority Review for the VIASKIN Peanut Patch in children aged 4-7 with peanut allergy.

The FDA previously granted Breakthrough Therapy Designation to the VIASKIN Peanut Patch.

This application is supported by positive results from the Phase 3 VITESSE trial, which enrolled 654 children and is described by DBV as the largest immunotherapy clinical trial to date for this population.

The VIASKIN Peanut Patch uses epicutaneous immunotherapy, a non-oral and non-injection approach that delivers small amounts of allergen protein through the skin to progressively desensitise children to peanut allergy.

DBV said the filing marks a milestone in its transition toward becoming a commercial organisation and follows years of clinical development and collaboration with the FDA and food allergy community.