Palforzia Now Available in US for Children Aged 1 – 3 years with Peanut Allergy

Credit: Adobe Stock/ Jiri Hera

Stallergenes Greer announced on Friday, February 28, 2025, that Peanut (Arachis hypogaea) Allergen Powder-dnfp (Palforzia®) oral immunotherapy is now available in the US for children aged 1 – 3 years with a confirmed peanut allergy.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,” said Stephen Tilles, MD, clinical professor of medicine at the University of Washington and medical consultant for Stallergenes Greer, in a statement.

The US Food and Drug Administration (FDA) approved Palforzia for children aged 1 – 3 years in July 2024. The decision was based on the phase 3 international, randomized, double-blind, placebo-controlled POSEIDON (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization) trial evaluating the efficacy and safety of Peanut (Arachis hypogaea) Allergen Powder-dnfp (Palforzia®) in children aged 1 – 3 years.² The trial had met all primary and secondary efficacy endpoints.¹

Palforzia is the only FDA-approved oral immunotherapy for managing peanut allergic reactions in patients aged 1 – 17 years. Recent studies have reported that young children, < 4 years, are in the critical therapeutic window for desensitizing peanut allergies with the immune system still developing. Starting treatment with Peanut (Arachis hypogaea) Allergen Powder-dnfp at an early age can help prevent the progression of peanut allergies.

Approximately 2% of children in the US have a peanut allergy, which could be life-threatening. Peanut allergies are linked to greater morbidity due to accidental exposure compared with other food allergies. Patients can try their best to avoid peanut allergens but still get accidental exposure—hence the importance of having safe and effective therapies for food allergies, especially for young children.

Dosing instructions for the peanut (Arachis hypogaea) Allergen Powder-dnfp indicate children aged 1 – 3 years should begin with a toddler-specific Initial Dose Escalation for the first-day dose escalation. Once the treatment reaches the current protocol for peanut (Arachis hypogaea) Allergen Powder-dnfp in peanut-allergy children aged 4 – 17 years, the dose can increase by 1 mg.

“Early intervention is critical in managing food peanut allergy, and the availability of Palforzia® as a treatment option provides an important opportunity for patients and their families to access proactive care,” Tilles said.

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. 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. Accessed February 28, 2025.

2. Fitch, J. Palforzia receives expanded label to treat toddlers with peanut allergy. Contemporary Pediatrics. July 30, 2024. https://www.contemporarypediatrics.com/view/palforzia-receives-expanded-label-to-treat-toddlers-with-peanut-allergy. Accessed February 28, 2025.