FDA Supports DBV’s Viaskin Peanut Patch For 4–7-Year-Olds, Eliminating Need For COMFORT Children Study

DBV Technologies, a clinical-stage biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has agreed with its proposal regarding the safety exposure data from the VITESSE Phase 3 study for the Viaskin® peanut patch in children aged 4 to 7 years. The FDA's Written Responses Only to DBV’s Type D IND meeting request confirmed that the existing data would be sufficient for a Biologics License Application (BLA) submission, eliminating the need for the previously planned COMFORT children supplemental safety study. This decision allows DBV to accelerate its BLA submission timeline, bringing the potential launch of the Viaskin peanut patch forward by approximately one year, pending regulatory approval. 

“DBV’s alignment with FDA represents a tremendous achievement for food allergy families, clinicians, researchers, and countless external partners that have been working for many years to advance the Viaskin peanut patch in children living with peanut allergy,” said Daniel Tassé, Chief Executive Officer, DBV Technologies. “I thank the FDA and the Review Team for their collaboration and constructive approach during the Type D meeting process, which enabled us to gain clarity expeditiously. DBV is commencing preparations for a BLA submission in the first half of 2026 to be supported by the Phase 3 VITESSE study, which is on track for the readout of topline results in the fourth quarter of 2025. We believe that the Viaskin peanut patch has the potential to change the lives of millions of children living with peanut allergies. This mission drives DBV every day. We will continue to work hard to bring this innovative treatment option to market.”

As a result, DBV will rely on safety data from VITESSE study participants who received active treatment, along with data from placebo-crossover participants in the VITESSE Open Label Extension (OLE) study. The BLA submission for children aged 4 to 7 is now expected in the first half of 2026. The VITESSE trial, which enrolled 654 participants, is the largest Phase 3 peanut allergy trial in this age group. By the time of the BLA submission, the safety database will include data from over 500 participants treated with the Viaskin peanut patch for at least 12 months.

Dr David Fleischer, FAAAAI, FACAAI, Global Principal Investigator, VITESSE, Professor of Pediatrics at Children’s Hospital Colorado, commented, “I am extremely pleased to see that FDA agrees that the VITESSE safety exposure data being generated is sufficiently robust to support a BLA in this age group. This is the largest, most rigorous study ever conducted in peanut-allergic children between 4 and 7 years of age. The insights that we will gain from this work are invaluable to the disease space as a whole. Clinicians want to see additional FDA-approved treatment options for food allergy so that we may conduct thoughtful conversations with our patients about which option is best for them and their lifestyle. I look forward to the day when the Viaskin peanut patch may be part of those conversations.”

Additionally, DBV is pursuing an Accelerated Approval pathway for toddlers aged 1 to 3 years with peanut allergies. The COMFORT Toddlers supplemental safety study is scheduled to begin in the second quarter of 2025, enrolling approximately 480 participants. The BLA submission for this younger age group is targeted for the second half of 2026, depending upon the successful completion of the trial. These regulatory advancements mark a significant step toward expanding treatment options for peanut-allergic children.

“On behalf of our 6,500 members in the United States and globally, we are pleased to support potential new innovations in food allergy, including the Viaskin peanut patch, that could add to the toolbox allergist-immunologists consider when treating patients. The ACAAI advocates for the best treatment outcomes for our patients under the care of their clinicians. We are encouraged by the robust dataset being generated by the VITESSE Phase 3 study, in which many of our members are currently serving as investigators. We continue to support DBV’s development of the Viaskin peanut program in this 4 – 7-year-old age group. Our community encourages as many treatment options as possible to reach those who are eagerly awaiting,” said Dr. James Tracy, DO, FACAAI, President, American College of Allergy, Asthma, and Immunology (ACAAI). “