DBV Technologies has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for the Viaskin Peanut Patch in children aged 4 through 7 years with peanut allergy, based on phase 3 VITESSE data.¹
The company announced the submission on September 29, 2026, and requested priority review; the FDA previously granted the patch Breakthrough Therapy Designation.¹ The filing follows the July 31, 2026, discontinuation of peanut (Arachis hypogaea) allergen powder-dnfp (Palforzia), the only FDA-approved oral immunotherapy for peanut allergy.2 If approved, Viaskin Peanut would offer a non-oral, non-injection epicutaneous immunotherapy (EPIT) delivering microgram amounts of peanut protein through intact skin.¹
"The submission of our BLA brings 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," said Daniel Tassé, chief executive officer, DBV Technologies. "This BLA reflects years of rigorous clinical development, meaningful contributions from the entire food allergy community, and ongoing collaboration with the FDA."¹
Viaskin Peanut Patch Efficacy in the Phase 3 VITESSE Trial
VITESSE was a global, randomized, double-blind, placebo-controlled phase 3 trial conducted at 86 sites across the United States, Canada, the United Kingdom, Europe, and Australia.¹ Investigators randomized 654 children aged 4 through 7 years 2:1 to the Viaskin Peanut Patch 250 µg (n = 438) or placebo (n = 216) for 12 months. 3 According to DBV, VITESSE is the largest immunotherapy trial conducted to date in this population.¹
The primary endpoint was the difference in the percentage of treatment responders between arms at 12 months.¹ Responders were children with a baseline eliciting dose (ED) of ≤ 30 mg who reached an ED of ≥ 300 mg of peanut protein, or children with a baseline ED of 100 mg who reached an ED of ≥ 600 mg.3 Investigators measured ED by double-blind, placebo-controlled food challenge. 3
At 12 months, 46.6% of children receiving the patch met responder criteria compared with 14.8% of children receiving placebo, a difference of 31.8 percentage points.3 The lower bound of the 95% CI for the difference was 24.5%, exceeding the prespecified threshold of 15%.3
Viaskin Peanut Patch Safety and Adherence in Children Aged 4-7
Safety findings in VITESSE were consistent with the profile observed across the Viaskin Peanut clinical program, according to DBV. 3 The most common treatment-emergent adverse events (TEAEs) were mild to moderate local skin reactions at the patch application site. 3 Adherence to daily patch application was 96.2%, in line with prior phase 3 Viaskin Peanut studies. 3
Additional VITESSE analyses presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2026 Annual Meeting showed a significantly greater proportion of responders with the patch vs placebo in both baseline ED strata.4 DBV reported most TEAEs in these analyses were mild local application site reactions, consistent with its previous phase 3 studies. 4
Following the 12-month double-blind period, children could enroll in an open-label extension in which all participants receive the patch for up to 3 years of total treatment.¹ Long-term data from the extension have not yet been reported. DBV described the patch as designed to progressively desensitize children by using the immune properties of the skin.¹
DBV is also evaluating the Viaskin Peanut Patch in toddlers aged 1 through 3 years with peanut allergy.¹ The release did not include a target action date, and the FDA has not yet announced a decision on priority review.¹
References
DBV Technologies highlights additional data from successful phase 3 VITESSE study at the AAAAI 2026 Annual Meeting. DBV Technologies. Published February 28, 2026. Accessed October 1, 2026. https://dbv-technologies.com/?p=23114
