DBV Submits BLA for Peanut Patch in Children

DBV Technologies, a late-stage biopharmaceutical company listed on Euronext and the Nasdaq Stock Market, today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the VIASKIN® Peanut Patch in children with peanut allergy aged 4 through 7 years. The BLA is supported by the results from the successful Phase 3 VITESSE trial, which is the largest immunotherapy clinical trial to date for this population.

The VIASKIN® Peanut Patch uses epicutaneous immunotherapy (EPIT), an innovative, non-oral, non-injection approach to food allergy treatment that delivers small amounts of an allergen protein through the skin. By using the immune properties of the skin, the VIASKIN® Peanut Patch is designed to progressively desensitize children to peanut allergy.

The BLA is supported by the positive results from the VITESSE Phase 3 clinical trial of the VIASKIN® Peanut Patch in 654 children aged 4 through 7 years with peanut allergy. VITESSE, a global Phase 3, randomized, double-blind, placebo-controlled clinical trial, evaluated the efficacy and safety of the VIASKIN® Peanut patch (250 µg) in children aged 4-7 years with peanut allergy. Conducted at 86 sites across the United States, Canada, the United Kingdom, Europe, and Australia, VITESSE represents the largest immunotherapy clinical trial for this patient population.

DBV Technologies, headquartered in Châtillon, France, and with North American operations in Warren, NJ, has requested Priority Review of the BLA. The FDA previously granted Breakthrough Therapy Designation to the VIASKIN® Peanut Patch.

The submission of the BLA brings the 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, marking a significant milestone in DBV’s transformation into a commercial organization.

DBV Technologies is a late-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. The company is currently focused on investigating the use of its proprietary VIASKIN® Patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT), the VIASKIN® Peanut Patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergens by leveraging the skin’s immune tolerizing properties. DBV Technologies is committed to transforming the care of people with food allergies.

DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market (DBVT, CUSIP: 23306J309). For more information, please visit www.dbv-technologies.com and engage with us on X (formerly Twitter) and LinkedIn.