Palforzia, the oral immunotherapy (OIT) for peanut allergy, is officially available for treatment in toddlers with peanut allergy in the United States. Stallergenes Greer, a global healthcare company, announced the launch on February 28, 2025 for children ages 1 to 3 years.
“The availability of an FDA-approved treatment for peanut-allergic toddlers is a significant breakthrough for families navigating peanut allergy. Parents now have a safe, effective, and potentially long-lasting option to help protect their young children,” says Dr. Stephen Tilles, an allergist in Washington state.
“Early intervention is critical in managing peanut allergy,” stresses Tilles, who is a medical consultant for Stallergenes Greer.
The FDA expanded Palforzia’s availability to younger children in July 2024 when it approved the treatment for toddlers with a diagnosed peanut allergy. Initially, it was approved for ages 4 to 17 years in 2020, making it the first-ever FDA-approved food allergy therapy.
The goal of the peanut oral immunotherapy is to protect patients against the risk of allergic reactions due to accidental consumption of peanut.
Tilles says that, “unlike peanut products obtained from a grocery store or online, this treatment offers precise and consistent dosing.” The allergist, who was a co-author on the large study that led to the approval for Palforzia’s peanut therapy, says this “provides peace of mind and a more controlled approach to managing peanut allergies.”
When the treatment gained FDA approval for younger children, Tilles told Allergic Living that starting the therapy at a young age is especially beneficial. At the toddler stage he said: “the young immune system is much more amenable to being fundamentally changed.”
Toddlers Study for Palforzia
The launch of Palforzia for toddlers follows regulatory approval based on research findings from the Phase 3 Poseidon study. A majority of participants on the treatment tolerated the equivalent of about two peanuts during any oral food challenge at the end of the double-blind clinical trial. But three-quarters of the patients could tolerate considerably more.
The study involved 146 peanut-allergic children ages 1 to 3 years. Participants took either Palforzia (98 toddlers) or placebo doses (48 toddlers) daily for 12 months. Patients on the treatment received gradually increasing daily doses up to 300 milligrams of Palforzia powder (equivalent to one peanut). They then continued on that as the maintenance dose.
At the study’s end, 74 percent of patients in the treatment group tolerated 600 mg of peanut protein powder in a single dose (about two peanuts). However, only about 6 percent in the placebo group managed to consume that amount.
In addition, 61 percent of the patients being treated could tolerate 2,000 mg of peanut protein (about 6 to 8 peanuts) compared to 2 percent on placebo.
The tolerated doses met the primary outcomes for the study, published in 2023 in the New England Journal of Medicine Evidence. Study authors wrote that the trial demonstrated Palforzia’s “superiority to placebo in inducing desensitization in peanut-allergic children.”
The availability of Palforzia to toddlers is, “addressing a significant unmet medical need in this younger patient population,” Tilles says.
Stallergenes Greer acquired Palforzia in September 2023 from Nestlé Health Sciences. Information about Palforzia, including providers, costs and the company’s co-pay program, can be found on its website.
Related Reading:
FDA Greenlights Palforzia OIT for Toddlers
In Toddlers, Peanut Allergy OIT Can Lead to Remission
