Palforzia® Oral Immunotherapy for Peanut Allergy Now Available for U.S. Children Aged 1-3
Stallergenes Greer Launches Palforzia® for Peanut Allergy in U.S. Toddlers Aged 1-3
Stallergenes Greer, a global leader in allergy therapeutics, has announced the launch of Palforzia® [Peanut (Arachis hypogaea) Allergen Powder-dnfp] in the U.S. for treating toddlers aged 1 to 3 years with a confirmed diagnosis of peanut allergy. This expansion marks an important milestone in the availability of treatments for peanut allergies in younger patients.
First FDA-Approved Oral Immunotherapy for Peanut Allergy
Peanut Arachis hypogaea is the first and only U.S. Food and Drug Administration (FDA)-approved oral immunotherapy (OIT) for the treatment of peanut allergy. The treatment is designed to mitigate allergic reactions, including potentially life-threatening anaphylaxis, caused by accidental exposure to peanuts. The approval covers pediatric patients aged 1 through 17 years.
Recent studies have identified a critical therapeutic window in peanut-allergic patients under 4 years of age, suggesting that early intervention can help prevent the progression of peanut sensitization. Early treatment with Palforzia® has shown the potential to help the immune system of young children better tolerate peanuts.
Peanut Allergy: A Growing Concern in U.S. Pediatrics
Peanut allergies currently affect approximately 2% of the U.S. pediatric population. Unlike other food allergies, peanut allergy often results in more severe reactions, even with strict allergen avoidance measures. This highlights the need for effective and safe therapies to manage the condition. It offers a promising option to help mitigate allergic reactions, reducing the risk of accidental exposure.
Addressing Unmet Medical Needs for Younger Children
Dr. Stephen Tilles, Clinical Professor of Medicine at the University of Washington and Medical Consultant for Stallergenes Greer, emphasized the significance of this launch: “We are delighted that Palforzia® is now available in the U.S. for children ages 1 through 3 years, addressing a significant unmet medical need in this younger patient population. 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.”
Palforzia® Oral Immunotherapy for Peanut Allergy Now Available for U.S. Children Aged 1-3
FDA Approval Based on Strong Clinical Data
The FDA approved the expanded indication for Palforzia® in toddlers aged 1 through 3 years in July 2024. This approval was based on data from the Phase 3 POSEIDON study, a critical clinical trial published in the New England Journal of Medicine Evidence in 2023. The study demonstrated the efficacy and safety of Palforzia® in young peanut-allergic children, meeting all primary and secondary endpoints, and confirming a favorable safety profile.
Dosing Protocol for Toddlers
Palforzia® dosing for peanut-allergic children starting therapy at ages 1 to 3 years includes a specific Initial Dose Escalation (IDE) tailored to toddlers. The first dose is carefully escalated, with a 1 mg up-dose level to ensure the patient’s safety. After the initial escalation phase, the treatment protocol aligns with the established up-dosing and maintenance guidelines for children aged 4 through 17 years, ensuring consistency and safety across different age groups.
Conclusion
The availability of Palforzia® for children as young as 1 year old marks a significant step forward in the management of peanut allergies. By addressing the critical window of intervention for this age group, Stallergenes Greer is offering a potential solution to a growing medical challenge, providing families and healthcare providers with a proactive tool to prevent life-threatening allergic reactions in young children.
Additional information about Palforzia®, including Boxed Warning, full Prescribing Information, Medication Guide and Prescription Enrollment Information, is available at www.PalforziaPro.com. Prescribers may also reach out to their local Palforzia® representative for more information or to be connected to a local PALFORZIA representative please contact [email protected].
ABOUT PALFORZIA®
Palforzia® is an oral immunotherapy treatment indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut for patients. PALFORZIA is approved for use in patients with a confirmed diagnosis of peanut allergy. Initial Dose Escalation may be administered to patients aged 1 to 17 years. Up-Dosing and Maintenance may be continued in patients 1 year of age and older.
ABOUT STALLERGENES GREER
Headquartered in Baar (Switzerland), Stallergenes Greer is a global healthcare company specializing in the diagnosis and treatment of allergies through the development and commercialization of allergen immunotherapy products and services. Supported by more than 100 years of expertise and innovation, our products are available for patients in over 40 countries.
For more information, visit www.stallergenesgreer.com.
