DBV Technologies (DBVT) FDA Approvals

DBV Technologies' Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by DBV Technologies (DBVT). Over the past two years, DBV Technologies has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Viaskin. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Viaskin Peanut (EPITOPE) FDA Regulatory Events

Viaskin Peanut (EPITOPE) is a drug developed by DBV Technologies for the following indication: Peanut-allergic toddlers ages 1 to 3 years. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Data Presentation - February 10,2026

• Drug: Viaskin Peanut (EPITOPE)
• Announced Date: February 10, 2026
• Indication: Peanut-allergic toddlers ages 1 to 3 years

DBV Technologies announced that the company will present additional data for the VIASKIN® Peanut Patch in children ages 4-7 years from the positive VITESSE Phase 3 study at the American Academy of Allergy, Asthma, and Immunology 2026 Annual Meeting, taking place in Philadelphia, PA February 27-March 2, 2026.

DBV Technologies will present additional data from the positive VITESSE Phase 3 study of the VIASKIN® Peanut Patch in children ages 4–7 at the American Academy of Allergy, Asthma, and Immunology (AAAAI) 2026 Annual Meeting in Philadelphia, PA, Feb 27–Mar 2, 2026. The oral abstract titled “VITESSE Phase 3 Study: Efficacy and Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children 4 Through 7 Years of Age” is scheduled for Feb 28, 2026, 2:15–2:25pm ET in the Clinical Science in Food Allergy session and will be presented by David Fleischer, MD.

DBV will also host a product theater on Feb 28, 10:00–10:30am ET, titled “Epicutaneous Immunotherapy (EPIT): Shaping the Future of Pediatric Food Allergy Treatment,” with panelists Hugh Sampson, MD; Katherine Anagnostou, MD, MSc, PhD; and S. Shahzad Mustafa, MD. Attendees can visit DBV at booth #1527 to learn more about EPIT and the VIASKIN Peanut Patch, early intervention, and how these approaches may change peanut allergy management.

FDA Meeting Request - March 24,2025

FDA Type D Meeting

• Drug: Viaskin Peanut (EPITOPE)
• Announced Date: March 24, 2025
• Indication: Peanut-allergic toddlers ages 1 to 3 years

DBV Technologies announced that in a Written Responses Only to the Company's Type D IND meeting request, the U.S. Food and Drug Administration (FDA) agreed with the Company's proposal that the safety exposure data from the VITESSE Phase 3 study for Viaskin peanut patch in 4 – 7-year-olds will be sufficient to support a Biologics License Application (BLA) filing in this age group.

DBV Technologies announced that the FDA has agreed—in a Written Responses Only to the Company’s Type D IND meeting request—that the safety exposure data from the VITESSE Phase 3 study will be sufficient for a Biologics License Application (BLA) for the Viaskin peanut patch in children aged 4 to 7 years. This agreement means that the supplemental COMFORT Children safety study is no longer required, allowing DBV to accelerate its BLA submission timeline to the first half of 2026. The decision is based on robust safety data generated from active treatment participants and those who crossed over to the open-label extension, covering over 500 children on Viaskin peanut patch treatment at the time of submission. The FDA’s alignment with DBV is seen as a major step forward in providing a new treatment option for children with peanut allergies.