Palforzia® Oral Immunotherapy for the Treatment of Peanut Allergy Now Available in the U.S. for Pediatric Ages 1 Through 3 Years

LENOIR, N.C. – Stallergenes Greer, a global leader in allergy therapeutics, today announced the launch of Palforzia^® [Peanut (Arachis hypogaea) Allergen Powder-dnfp] in the U.S to treat toddler patients, ages 1 through 3 years, with a confirmed diagnosis of peanut allergy.

Palforzia^® is the first and only U.S Food and Drug Administration (FDA) approved oral immunotherapy treatment (OIT) for the mitigation of allergic reactions, including anaphylaxis that may occur with accidental exposure to peanut for patients ages 1 through 17 years.¹

Recent studies in peanut-allergic patients <4 years of age indicate the presence of a critical therapeutic window in the youngest participants, during which the immune system is still developing². Early treatment with Palforzia^® helped prevent the progression of peanut sensitization¹.

Peanut allergy currently affects approximately 2% of the US pediatric population^3-4. Compared to other food allergies, peanut allergy is associated with higher rates of morbidity due to accidental exposure⁵. The severity of reactions in some patients despite strict allergen avoidance efforts highlights the need for safe and effective therapies.⁶

“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 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,” says Stephen Tilles, MD, Clinical Professor of Medicine at the University of Washington and Medical Consultant for Stallergenes Greer.

The FDA approved the expanded indication for toddler patients (ages 1 through 3 years) in July 2024 based on the data from the Phase 3 POSEIDON (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization) study that was published in the New England Journal of Medicine Evidence in 2023. The study evaluated the efficacy and safety of Palforzia^® in peanut-allergic children aged 1 to 3 years old, meeting all its primary and secondary efficacy endpoints and demonstrating a favorable safety profile.

Palforzia^® dosing in peanut-allergic children who begin therapy between the ages of 1 through 3 years includes a toddler specific Initial Dose Escalation (IDE) for the first day dose escalation, as well as a 1 mg up-dose level, after which the treatment regimen aligns to the current up-dosing protocol and maintenance protocol for Palforzia^® in peanut-allergic children ages 4 through 17 years.¹

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.

Palforzia^® is to be used in conjunction with a peanut-avoidant diet.

Limitation of Use: Not indicated for the emergency treatment of allergic reactions, including anaphylaxis.

Palforzia^® is approved by the U.S. Food and Drug Administration (FDA) for ages 1 through 17 years.

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.

¹ PALFORZIA [package insert]. Lenoir, NC; Greer Laboratories, Inc.
²Jones 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;399:359-371
³Bilaver LA, Chadha AS, Doshi P, O’Dwyer L, Gupta RS. Economic burden of food allergy: A systematic review. Ann Allergy Asthma Immunol 2019;122:373–80 e1.
⁴Gupta RS, Springston EE, Warrier MR, et al. The prevalence, severity, and distribution of childhood food allergy in the United States. Pediatrics 2011;128:e9–17.
⁵The global burden of illness of peanut allergy: A comprehensive literature review. Jay A. Lieberman, Ruchi S Gupta, Rebecca C. Knibb, Tmirah Haselkorn, Stephen Tilles, Douglas P. Mack, and Guillaume Pouessel. Online: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8247890/. Accessed August 31, 2023
⁶ Bock SA, Muñoz-Furlong A, Sampson HA. Fatalities due to anaphylactic reactions to foods. J Allergy Clin Immunol. 2001;107:191-3. Accessed August 31, 2023.