After five years of daily use, the Viaskin peanut patch desensitized 73 percent of older children and teens, new research finds.
The children in the trial started wearing the patch between the ages of 4 to 11. They were up to age 16 by the end.
The study found 73 percent could eat at least 300 milligrams (mg), or about one peanut, before starting to react. Most – 67 percent – could consume 3 to 4 peanuts without symptoms.
The Viaskin Peanut patch, made by DBV Technologies, gradually exposes children to their allergen through the skin to build tolerance.
Dr. Pharis Mohideen, DBV’s chief medical officer, says this long-term data should give families and physicians peace of mind. The company is pursuing approval of the patch in children ages 1 to 7, meaning that’s the age when children could start treatment.
But children would remain on the patch for years. Families may wonder if the patch will continue to work as their child grows, he says. The new study results show that “yes, you can stay on the product,” he says.
Children won’t need a higher dose as they age, and protection in many continues to improve into older childhood and adolescence.
“The safety profile continues to improve over time and the efficacy continues to improve over time,” Mohideen says. “The efficacy is not surprising. We know that for allergen immunotherapy, Year 2 tends to be better than Year 1, Year 3 better than Year 2, and so on.”
The study is being presented at the 2025 AAAAI/World Allergy Joint Congress in San Diego.
Viaskin Patch – ‘So Safe’
The children were initially enrolled in a Phase 3 study, PEPITES. In 2017, researchers reported that one year of patch wearing desensitized 35 percent children ages 4 to 11. Although those results were disappointing, desensitization rates did rise with longer patch use.
A 2020 extension study, PEOPLE, included 298 children. It found that after three years of patch use, 52 percent of kids could eat 3 to 4 peanuts before starting to react. About 29 percent of the children in PEOPLE opted to continue in the trial for two more years.
This latest study, representing five years of daily patch use, shows even better desensitization rates.
Modiheen notes there were no dropouts in Year 3 of the trial or later for adverse events, and no treatment-related uses of epinephrine.
“Because we are going through the skin, there is no ingestion of peanut protein,” he says. “In animal studies, we cannot detect the peanut protein in the blood. We think it’s one reason why it [the patch] is so safe.”
Peanut Allergy Patch & Young Children
Though welcome data in teens and older kids, in August 2020, the company had switched gears and decided to pursue approval of the patch only for younger children ages 1 to 7. This was after the U.S. Food and Drug Administration declined to approve the patch in children 4 to 11.
New studies were launched, testing a patch in kids ages 1 to 3 and another in 4 to 7. In 2023, a Phase 3 trial (EPITOPE) and an extension trial of the patch in the toddler group showed very strong results. After two years of wearing the patch, 81 percent of peanut-allergic children ages 1 to 3 could tolerate 3 to 4 peanuts without reacting.
About 56 percent could consume even more – 12 to 14 peanuts – without signs of a reaction.
Three-year results continued to show improvement – 68 percent of toddlers could consume 12 to 14 peanuts without reacting. Mohideen called the results “spectacular.”
The FDA is satisfied with the efficacy results in toddlers and has not asked for additional studies, Mohideen says. Before submitting for approval, the company needs to complete a supplemental safety study, called Comfort Toddlers. That study will launch this spring, he says.
Therapy in Kids Ages 4 to 7
DBV is also testing a patch in children ages 4 to 7. This patch was redesigned in 2020 and is somewhat larger than the toddler patch.
More than 650 children are enrolled in that one-year trial (VITESSE), with results expected by the end of 2025. DBV then need to conduct a supplemental safety study.
They plan to submit for approval for the patch for toddlers and 4-to-7 year-olds in the second half of 2026, Mohideen says.
Mohideen sees the Viaskin patch as appealing to parents of very young children who may not be willing to consume peanut as part of oral immunotherapy (OIT). Currently, there is one FDA-approved OIT on the market for children ages 1 to 7, Palforzia, for peanut allergy.
Also, the patch may appeal to parents who do not want to give their child Xolair injections, which some find painful. Xolair was approved by the FDA in 2024 to prevent reactions from accidental exposures to small amounts of multiple food allergens.
As children reach their tweens or adolescence, kids may be more willing to receive Xolair injections. Or, after building tolerance with the Viaskin patch, they could potentially switch to eating a few peanuts a day as maintenance, he says.
“Now the conversation has shifted from just pure avoidance to, ‘hey, what are my therapeutic options?’ It’s a different landscape now, and I think it’s a much better one.”
Related Reading:
DBV Upbeat on Allergy Patch Studies, Approval Chances
FDA Greenlights Palforzia OIT for Toddlers with Peanut Allergy
Allergy Mom Video: the Silver Lining in a ‘Failed’ Food Challenge
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