DBV Technologies announced on September 29, 2026, that it submitted a Biologics License Application (BLA) to the US Food & Drug Administration (FDA) for the Viaskin Peanut Patch in children aged 4 to 7 years with peanut allergy.¹ The company requested Priority Review, and the FDA previously granted the patch Breakthrough Therapy designation.¹
The filing comes 2 months after Palforzia (peanut allergen powder-dnfp), the only FDA-approved oral immunotherapy (OIT) for peanut allergy, was discontinued on July 31, 2026.2 Stallergenes Greer said the discontinuation was not related to product safety, quality, or efficacy. Until the FDA acts on the patch, omalizumab is the only FDA-approved therapy on the market for IgE-mediated food allergy.3
This FAQ covers what the BLA includes, how the phase 3 VITESSE trial defined a responder, which patients the data apply to, and how the patch would sit beside omalizumab and office-based OIT.
Q: What is in the Viaskin Peanut BLA?
A: The BLA seeks approval of the Viaskin Peanut Patch, an epicutaneous immunotherapy that delivers 250 µg of peanut protein through intact skin, for children aged 4 to 7 years.¹ It is supported by VITESSE, a phase 3, randomized, double-blind, placebo-controlled trial of 654 children at 86 sites in the US, Canada, the UK, Europe, and Australia.4
As of October 8, 2026, the FDA has not announced whether it will grant a priority review or a target action date.¹ The patch remains investigational and is not FDA approved for any age group.¹
Children who completed the 12-month double-blind period could enter an open-label extension and receive the patch for up to 3 years in total.¹ Long-term extension data in this age group have not been reported.
Q: How did VITESSE define a responder, and what did it show?
A: At 12 months, 46.6% of children on the patch met responder criteria vs 14.8% on placebo, a difference of 31.8 percentage points (95% CI, 24.5-39.0; P < .0001).4
Response was defined by the eliciting dose (ED) on a double-blind, placebo-controlled food challenge, scaled to each child's baseline:4
- Baseline ED of ≤ 30 mg peanut protein: responder if the 12-month ED reached ≥ 300 mg
- Baseline ED of 100 mg: responder if the 12-month ED reached ≥ 600 mg
Q: Which patients would be candidates for the patch?
A: The BLA covers children aged 4 to 7 years only.¹ The final label will set eligibility, but the VITESSE population offers the best preview of who the data apply to:4
- Peanut-specific IgE above 0.7 kUA/L
- Skin prick test wheal of 6 mm or more
- Reaction to ≤ 100 mg of peanut protein on a double-blind, placebo-controlled food challenge
The trial enrolled children with low reaction thresholds, so the results speak most directly to highly sensitive patients in this age range. No BLA has been announced for children younger than 4 years, older children, or adults.¹
The patch is applied daily, and mean compliance in VITESSE was 96.1% in the active group.4 That makes it a potential fit for families who want a non-oral, non-injection option that does not require daily ingestion of the allergen.
Q: What does the safety profile look like?
A: Local application-site reactions drove most adverse events, and treatment-related anaphylaxis occurred in 2 of 438 children (0.5%) on the patch. 4 No treatment-related serious adverse events occurred in either group.²
Treatment-related adverse events
Treatment-related local reactions
Treatment-related anaphylaxis
Treatment-related events treated with epinephrine
Discontinuation due to adverse events
Treatment-related serious adverse events
Source: VITESSE primary results, Eastern Allergy Conference 2026 poster.4
Q: Where do omalizumab and office-based OIT fit while the patch is under review?
A: Omalizumab has been FDA approved since February 16, 2024, to reduce allergic reactions, including anaphylaxis, from accidental exposure to 1 or more foods in patients aged ≥ 1 years.3 It is given as an injection with continued food avoidance, and it carries a boxed warning for anaphylaxis.5
In stage 1 of the OUtMATCH trial, 67% of children on omalizumab tolerated a single dose of 600 mg or more of peanut protein after 16 to 20 weeks vs 7% on placebo.6
Stage 2 of OUtMATCH compared omalizumab with omalizumab-facilitated multiallergen OIT in 117 participants allergic to peanut and ≥ 2 other foods.7 In the intention-to-treat analysis, 36% on omalizumab vs 19% on OIT tolerated ≥ 4044 mg of all 3 foods, with no difference in the per-protocol analysis.7
In the OIT group, 31% had serious adverse events, 22% stopped because of adverse events, and 37% needed epinephrine, vs 0%, 0%, and 7% with omalizumab.⁶
Office-based OIT with peanut or peanut flour continues without an FDA-approved product.2 It follows standardized protocols, is not FDA approved, and insurance coverage varies.2
Age at start matters. In the IMPACT trial of children aged 1 to 3 years, 71% on peanut OIT were desensitized at 134 weeks vs 2% on placebo, and 21% vs 2% met remission criteria after 26 weeks of avoidance, with younger age predicting remission.8
Q: How should clinicians weigh the patch, omalizumab, and OIT with families?
A: The choice turns on how many foods a patient reacts to, the child's age, and how much daily allergen dosing and reaction risk a family can manage.
Investigational; BLA filed¹
Approved for IgE-mediated food allergy3
No approved product since July 31, 20262
1 to 3 years in IMPACT8; protocols vary in practice
Injection every 2 to 4 weeks3
Daily oral peanut or peanut flour2
Food used in the protocol
46.6% vs 14.8% responders at 12 months4
67% vs 7% tolerated 600 mg or more of peanut6
71% vs 2% desensitized; 21% vs 2% remission8
Local skin reactions in 90.9%4
Boxed warning for anaphylaxis; requires continued avoidance5
Dosing reactions and epinephrine use; 22% stopped multiallergen OIT for adverse events in OUtMATCH7
For families of children aged 4 to 7 who are considering waiting for the patch, there is no FDA decision date yet.¹ For younger children, the IMPACT finding that earlier OIT start predicted remission is worth raising when families ask whether to wait.⁷
Q: What could the toddler program add?
A: The toddler data could extend the patch to children aged 1 to 3 years, but DBV has not announced a toddler BLA or its timing. Recruitment for COMFORT Toddlers, a supplemental safety study in this age group, closed in the second quarter of 2026.9
In the phase 3 EPITOPE trial of 362 children aged 1 to 3 years, 67% on the patch met the primary endpoint vs. 33.5% on placebo (risk difference, 33.4 percentage points; 95% CI, 22.4-44.5).9 Treatment-related anaphylaxis occurred in 1.6% of the patch group and none on placebo.9
Responses deepened with longer use. In the open-label extension, 81.3% of children treated for 24 months reached an ED of ≥ 1000 mg, with no treatment-related anaphylaxis in year 2 for that group.⁹ Because early intervention is linked to better outcomes, a toddler indication would bring the patch into the age window that IMPACT linked to higher remission rates with peanut OIT.⁷
This FAQ reflects the regulatory status of the Viaskin Peanut Patch, omalizumab, and peanut oral immunotherapy as of October 8, 2026. The Viaskin Peanut Patch is investigational and not FDA approved, and the FDA has not announced a review classification or action date for the September 2026 BLA. Additional approvals, label changes, or guideline updates are likely, so readers should confirm current status and check the current prescribing information for any approved therapy before relying on this content for clinical decisions.
References
Fleischer DM, Mack DP, Wang J, et al. VITESSE phase 3 trial: efficacy and safety of epicutaneous immunotherapy in children with peanut allergy aged 4 through 7 years. Poster presented at: Eastern Allergy Conference; 2026. Accessed October 8, 2026. https://dbv-technologies.com/wp-content/uploads/2026/05/EAC_VITESSE_Primary_Encore_Poster_Print_Ready.pdf
Wood RA, Togias A, Sicherer SH, et al. Omalizumab for the treatment of multiple food allergies. N Engl J Med. 2024;390(10):889-899. doi:10.1056/NEJMoa2312382
Wood RA, Togias A, Burk CM, et al. Treatment of multifood allergy with omalizumab or multiallergen oral immunotherapy: a randomized clinical trial. JAMA Pediatr. 2026;180(10):1067-1075. doi:10.1001/jamapediatrics.2026.2910
Jones SM, Kim EH, Nadeau KC, et al. Efficacy and safety of oral immunotherapy in children aged 1-3 years with peanut allergy (the Immune Tolerance Network IMPACT trial): a randomised placebo-controlled study. Lancet. 2022;399(10322):359-371. doi:10.1016/S0140-6736(21)02390-4
Greenhawt M, Sindher SB, Wang J, et al. Phase 3 trial of epicutaneous immunotherapy in toddlers with peanut allergy. N Engl J Med. 2023;388(19):1755-1766. doi:10.1056/NEJMoa2212895
Greenhawt M, Albright D, Anvari S, et al. Efficacy and safety of epicutaneous immunotherapy in peanut-allergic toddlers: open-label extension to EPITOPE. J Allergy Clin Immunol Pract. 2025;13(5):1176-1187.e7. doi:10.1016/j.jaip.2025.02.004
DBV Technologies reports second quarter and half-year 2026 financial results and business update. News release. DBV Technologies. July 16, 2026. Accessed October 8, 2026. https://dbv-technologies.com/?p=23763
