Palforzia launches in US for toddlers with peanut allergy

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Stallergenes Greer has announced the US launch of Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] for children aged 1 through 3 years with a confirmed diagnosis of peanut allergy. Palforzia® is the first and only FDA-approved oral immunotherapy (OIT) designed to mitigate allergic reactions, including anaphylaxis, following accidental peanut exposure in patients aged 1 through 17 years.¹

“We are delighted that Palforzia is now available in the US for children ages 1 through 3 years, addressing a significant unmet medical need in this younger patient population. Early intervention is critical in managing peanut allergy, and the availability of Palforzia as a treatment option provides an important opportunity for patients and their families to access proactive care,” said Stephen Tilles, MD, clinical professor of medicine at the University of Washington and Medical Consultant for Stallergenes Greer.¹

The launch follows recent findings that suggest early intervention with oral immunotherapy may offer significant benefits for young children. The phase 3 POSEIDON study provided data supporting the FDA’s expanded approval for toddlers in July 2024. Further evidence comes from the Immune Tolerance Network’s IMPACT trial, a randomized, placebo-controlled study evaluating the efficacy and safety of peanut oral immunotherapy in children under age 4.²

Key findings from the IMPACT trial

The IMPACT trial, conducted across five U.S. academic centers, studied the effects of peanut oral immunotherapy (PnOIT) in 146 children between 12 and 48 months of age. Participants were randomized in a 2:1 ratio to receive either PnOIT or placebo over a 134-week treatment period, followed by a 26-week period of peanut avoidance.²

Results showed that 71% of PnOIT-treated participants were desensitized to 5000 mg of peanut protein by the end of treatment, compared to just 2% in the placebo group. Additionally, 21% of PnOIT-treated children met the criteria for remission after the avoidance phase, meaning they could tolerate 5000 mg of peanut protein without developing symptoms. Younger age and lower baseline peanut-specific IgE levels were predictive of remission outcomes.²

The study also provided long-term safety data on PnOIT in young children. Although 98% of PnOIT-treated participants experienced at least one dose-related reaction, the majority were mild to moderate, and serious adverse events were not observed. Epinephrine was administered for 35 dosing reactions in 21 participants over the 134-week treatment period, primarily during at-home maintenance dosing.²

Dosing and administration

Palforzia treatment for toddlers includes an initial dose escalation (IDE) phase, including a toddler-specific IDE for the first-day dose escalation, followed by a 1 mg up-dose level. After this, the treatment regimen aligns with the existing protocol for children aged 4 through 17 years. Palforzia is intended to be used in conjunction with a peanut-avoidant diet and is not indicated for the emergency treatment of allergic reactions.³

References:

1. Palforzia Oral Immunotherapy for the Treatment of Peanut Allergy Now Available in the U.S. for Pediatric Ages 1 Through 3 Years. Businesswire. February 28, 2025. Accessed February 28, 2025. https://www.businesswire.com/news/home/20250228357515/en/Palforzia%C2%AE-Oral-Immunotherapy-for-the-Treatment-of-Peanut-Allergy-Now-Available-in-the-U.S.-for-Pediatric-Ages-1-Through-3-Years

2. 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