For over a decade, the food allergy community has waited for the Viaskin patch for peanut allergy to achieve long-awaited Food and Drug Administration approval. But the patch saga has had many twists and turns, leaving some to wonder if they should keep hoping.
Today, DBV Technologies, the company developing the allergy patch, says there are new and exciting reasons for optimism. They’re making progress in key studies for peanut and now, milk. Patch formulations to treat more allergens, including cashew and potentially others, are planned.
“We are doing everything in our power to get our product to the marketplace as soon as we can,” says Dr. Pharis Mohideen, DBV’s chief medical officer. While getting Viaskin Peanut approved is their first goal, “we have a strong pipeline after that for foods like milk and cashew.”
Also promising: the FDA recently granted the peanut patch for toddlers “accelerated approval,” a designation meant to fast-track its availability. The designation is for drugs for serious conditions where therapy choices are lacking, and it signals the agency’s interest, Mohideen says.
It’s reserved for products that the FDA thinks have “a very good chance of being approved,” Mohideen says. “From a regulatory standpoint, the path is very clearly defined for us, and we just have to execute it. We are really happy with where we are now.”
Peanut Allergy Patch: Study Milestones
The company plans to launch a supplemental safety study in mid-2025 for their peanut allergy patch in children ages 1 to 3. That study, called Comfort Toddlers, will bring the total number of toddlers treated to nearly 600, as the FDA requested.
This trial follows the EPITOPE Phase 3 trial published in the New England Journal of Medicine and an open-label extension trial, which both showed strong results. After two years of wearing the Viaskin Peanut patch, 81 percent of peanut-allergic toddlers could tolerate 3 to 4 peanuts without reacting.
About 56 percent could consume even more – 12 to 14 peanuts – without signs of a reaction. This tolerance level was despite having reacted to an average of one-third of a peanut at the trial’s outset. “It’s a huge gain,” Mohideen says.
Viaskin Patch for Older Children
The company has also finished recruitment for VITESSE, a one-year trial which will test the allergy patch in kids ages 4 to 7. Results are expected by the end of 2025, Mohideen says.
The company will also need to do an additional safety study in 4-to-7-year-olds, similar to the supplemental toddler study.
After the peanut trials are complete, the company will submit its data for FDA approval. No timeline for that has been announced yet.
Expanding DBV Patch to Milk and More
DBV isn’t stopping at peanut. They plan to use the patch technology to treat other food allergies, Mohideen says. Ideas include a “breakfast patch” containing milk and egg, or multiple tree nuts on one allergy patch. “That is years down the road, but these are things I can dream of with the platform we have.”
Next up: milk. A Phase 2 study published in JAMA Pediatrics focused on finding the optimal dose for desensitizing milk-allergic children. Children ages 2 to 17 were placed into a low-dose, middle- or high-dose Viaskin Milk patch group, or a placebo patch group.
After one year, 49 percent of children in the middle-dose group could tolerate at least 10 times more than the amount they tolerated at the start of the study. Nearly 43 percent in the mid-dose group could consume 1,444 milligrams without a reaction. Children ages 2 to 11 responded better than teens.
To the surprise of researchers, the middle-dose group responded better than the group wearing the high-dose allergy patch. They believe that milk protein is “sticky” and the higher dose may have stuck to the patch, hindering absorption, while the middle dose was more readily absorbed.
One child in the highest dose group experienced treatment-related anaphylaxis, but other reactions were mostly mild at the site of the patch. DBV researchers are refining the dosage and working on a follow-up Phase 2 Viaskin Milk study. Cashew and possibly sesame are next in line, Mohideen says.
Viaskin Patch’s Winding Journey
The Viaskin patch is a form of epicutaneous immunotherapy, or EPIT. The patch delivers minute amounts of allergen through the skin, with the intent to build tolerance over time. The amount of peanut protein contained in the patch is about 250 micrograms. (By comparison, the starting dose for Palforzia, the FDA-approved oral immunotherapy product for peanut allergy, is 500 micrograms. Patients build up to a maintenance level of 300 milligrams.)
But the road to approval for DBV’s therapy has been complicated. A 2017 Phase 3 study, PEPITES, was disappointing. That trial found that after one year of wearing the patch, only 35 percent of kids ages 4 to 11 were desensitized to peanut. That compared to about 14 percent using a placebo patch.
A subsequent study showed better results in this group after wearing the patch for an additional two years. Fifty-two percent of kids tolerated 3 or 4 peanuts.
Then in August 2020, the FDA declined to approve the patch for children aged 4 to 11. One concern cited was that patch adhesion might be impacting its effectiveness. So the company designed and now studies a slightly larger patch for children ages 4 and up. Meanwhile, the studies in the children ages 1 to 3 continued uninterrupted, using the original patch design.
Along the way, researchers have spotted intriguing hints about the potential of EPIT to induce lasting tolerance, Mohideen says. With OIT, patients must continue regular consumption of their allergen to maintain desensitization. Without that, immune system cells “remember” the allergy and symptoms can return upon allergen exposure.
With the Viaskin patch, the protein is absorbed into the lymphatic system. Although researchers aren’t entirely sure why, there are indications this interaction with immune cells in the lymphatic system may result in “sustained unresponsiveness,” even after patch-usage is stopped. “It’s early, but it’s really exciting to us,” he says.
Allergy Therapies: Where Does Patch Fit?
Since the Viaskin patch development began, the allergy treatment landscape has evolved. The FDA approved Palforzia for peanut-allergic children aged 4 to 17 in 2020. Then after further study, it expanded the approval in August 2024 to children ages 1 to 3.
Also in 2024, the FDA approved omalizumab (the brand Xolair), the first treatment for multiple food allergies. The biologic medication, which is given by injection every two or four weeks, is for children and adults ages 1 and older. It is intended to prevent serious reactions due to accidental exposure to food allergens. Patients on Xolair are still advised to avoid eating their allergens, though some research suggests patients on the drug may be able to safely consume more.
Mohideen sees the Viaskin patch fitting in with these other options, either as an alternative or in conjunction. Because younger kids seem to respond best, the company is focusing on approval of the patch in children 7 and under, he says.
In young children, he says some families may find applying a patch once daily easier than OIT. Oral immunotherapy typically requires consuming an amount of allergen every day, and a rest period. The patch eliminates the need for a rest period. “You put the patch on and go about your day,” Mohideen says.
Or, families might want to start with the patch, and later transition to OIT, he says.
New Treatments, New Decisions
Since younger kids tend to struggle more with Xolair shots, the DBV team sees the patch as a potential alternative to injections. Kids might be willing to switch to Xolair shots as they got older, Mohideen says.
While waiting for the clinical trials to wrap, researchers and physicians frequently approach DBV staff with ideas for future research. Or, they suggest how they’d like to use the patch in their practices if approved, Mohideen says.
Not long ago, the main advice to families was to avoid their child’s allergens. “Now, with the new treatment options, we can have that shared decision-making,” he says. “Do I want to try omalizumab? Do I want to do OIT?”
Soon, he hopes, discussions will include, “Do I want to do the patch? Patients just want options.”
Viaskin Patch Photo: DBV Technologies notes this photo is for illustration only as this product has not received FDA approval.
Related Reading:
Viaskin Peanut Patch Desensitized 81% of Toddlers By 2 Years
FDA Greenlights Palforzia OIT for Toddlers with Peanut Allergy
Experts on Rewards, Risks of Baked Milk and Egg Allergy Challenges
