Palforzia (peanut (Arachis hypogaea) allergen powder-dnfp) / Nestle - LARVOL DELTA

Modulating the Allergen-Specific Immune Response to Achieve Remission of Food Allergy Through Oral Immunotherapy. (PubMed, Adv Exp Med Biol) - "Oral immunotherapy (OIT) is effective at inducing desensitization, defined as a temporary increase in reaction threshold to food allergens, and a low-dose OIT approach (Palforzia) is now approved in several regions, including the United States, the United Kingdom, and the European Union...Gene expression studies in patient samples from clinical OIT trials have provided insight into the immune pathways involved in redirecting the allergic response toward tolerance, with changes in allergen-reactive T cells, B cells, and baseline signatures. This chapter aims to provide an overview of the immune changes underlying food allergy and the immune mechanisms of OIT that lead to remission of allergy."

IO biomarker • Journal • Allergy • Food Hypersensitivity • Immunology

Current Food Allergy Treatment Options. (PubMed, Immunol Allergy Clin North Am) - "Historically, allergen avoidance, anaphylaxis education, and prompt use of intramuscular epinephrine were the only treatment options. Now, there are 2 Food and Drug Administration-approved products (Palforzia and Xolair), which can help reduce the risk of severe food allergy reactions. There is ongoing research regarding the use of immunotherapy (oral, sublingual, and epicutaneous), other monoclonal antibodies (eg, dupilumab), probiotics and microbiome manipulation, and traditional Chinese medicine."

Journal • Review • Allergy • Food Hypersensitivity • Immunology

Staggered oral peanut challenge with regular consumption at home (EAACI 2025) - "Background To share our experience of staggered oral peanut challenge in children due to Palforzia being unavailable in Ireland Method Staggered Oral Peanut Challenge with regular consumption at home Results 11 children developing tolerance to Peanut. Conclusion This approach provides an affordable solution to children with peanut allergies."

Food Hypersensitivity • Immunology

Scientific developments in understanding food allergy prevention, diagnosis, and treatment. (PubMed, Front Immunol) - "Currently there are two approved drugs for the treatment of FA, Palforzia and Omalizumab. However, they are time-consuming and involve risk of anaphylaxis; therefore, alternative diagnostic methods are being evaluated. This review will discuss how the immune system mediates an allergic response to specific foods, as well as FA risk factors, diagnosis, prevention, and treatments for FA."

Journal • Review • Allergy • Food Hypersensitivity • Immunology

Emerging therapeutics in the management of food allergy. (PubMed, Curr Probl Pediatr Adolesc Health Care) - "In this review, we outline the clinical management of food allergy, including mainstream non-pharmaceutical therapies, such as food oral immunotherapy (OIT), as well as three FDA-approved therapies: Palforzia (pharmaceutical peanut oral immunotherapy), omalizumab (anti-IgE monoclonal antibody), and Neffy (intranasal epinephrine). We also discuss emerging therapies, including novel routes of immunotherapy administration (epicutaneous, subcutaneous, sublingual, oral mucosal) and existing immunomodulatory therapies undergoing trials for use in food allergy, including dupilumab (anti-IL-4 and IL-13 monoclonal antibody), abrocitinib (oral JAK inhibitor) and abatacept (IgG-CTLA-4 fusion protein)."

Journal • Allergy • Food Hypersensitivity • Immunology • CTLA4 • IL13 • IL4

Palforzia Oral Immunotherapy for the Treatment of Peanut Allergy Now Available in the U.S. for Pediatric Ages 1 Through 3 Years (Businesswire) - "Stallergenes Greer...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....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..."

Launch US • Allergy

Moving beyond desensitization to tolerance in food allergy. (PubMed, J Allergy Clin Immunol Pract) - "Management of IgE-mediated food allergy is shifting from reactive management strategies (allergen avoidance and ready access to autoinjectable epinephrine in case of exposure) to proactive therapies. These therapies are in various stages of clinical development and implementation; the two main approaches include allergen-specific/active therapies (induce the immune system to produce a protective response to the allergen; e.g., FDA-approved AR101/Palforzia for peanut allergy), and allergen-agnostic, passive therapies (provide the body with the tools needed to suppress immediate hypersensitivity reactions in a non-specific manner; e.g., FDA-approved omalizumab/xolair)...As the food allergy management repertoire expands, important considerations in selecting a therapy will be patient-specific and include mode of delivery, dosing regimens, side effect profiles and goals/outcomes. The role of shared decision making and implementation strategies to support equitable access..."

Journal • Allergy • Food Hypersensitivity • Immunology

Peanut Genotypes with Reduced Content of Immunogenic Proteins by Breeding, Biotechnology, and Management: Prospects and Challenges. (PubMed, Plants (Basel)) - "Recent advancements in oral immunotherapy, such as Palforzia™, and IgE-mediated treatments (e.g., Xolair), have improved care options; however, their high costs limit accessibility and widespread utility. This communication examined the impact of peanut allergies worldwide and explored strategies to develop peanut genotypes with reduced allergen content, including conventional breeding and advanced genetic engineering. It also addressed the challenges associated with these approaches, such as policy and regulatory hurdles, and outlined key requirements for their successful adoption by farmers and consumers."

Journal • Allergy • Food Hypersensitivity • Immunology

Impact of Socioeconomic Status on Knowledge and Attitudes Towards Treatment of Food Allergies (ISKAT-FA) (AAAAI-WAO 2025) - "Among them, 12 parents (70.5%) had children with peanut allergy, and 6 (50%) knew about Palforzia, 5 (41.6%) knew about omalizumab, while 5 (41.6%) were unaware of either treatment. Conclusions Higher SES families appear to have greater awareness of food allergy-specific treatments, which might influence their treatment choices. Larger studies are needed to determine the exact association between SES and food allergy awareness and how to leverage this knowledge among all families."

Allergy • Food Hypersensitivity • Immunology

European Commission Approves the Extension of the Indication of Palforzia to the Treatment of Toddlers With Confirmed Peanut Allergy (Businesswire) - "Stallergenes Greer...announces that the European Commission (EC) has approved the extension of indication of Palforzia (defatted powder of Arachis hypogaea L., semen (peanut)) for the treatment of toddlers (ages 1 through 3) with a confirmed diagnosis of peanut allergy...The approval is based on 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."

EMA approval • Food Hypersensitivity

Dupilumab as an Adjunct to Oral Immunotherapy in Pediatric Patients With Peanut Allergy. (PubMed, Allergy) - P2 | "Dupilumab provided a modest increase efficacy of OIT in children and adolescents with peanut allergy, though it did not provide protection against OIT-related anaphylaxis."

Clinical • Journal • Allergy • Food Hypersensitivity • Immunology • Pediatrics • IL13

Gynostemma pentaphyllum saponins shield mice from peanut allergy by modulation of gut microbiota: A novel approach for peanut allergy management. (PubMed, Phytomedicine) - "To conclude, we revealed the intestinal environment, signaling molecules, mucosal cytokines, and commensal microbial profiles in the peanut-sensitized mouse model. We further presented evidence for the protective effect of GpS against PN allergen sensitization by downregulating a series of food-allergy-associated biomarkers and cytokines via the modulation of gut bacteria. More importantly, supported by both in vitro and in vivo experiments, we demonstrated that the protective effect of GpS against PN-allergy is through the enhancement of two commensal bacteria, Clostridium aldenese, and Lactobacillus murinus."

Biomarker • Clinical • Clinical protocol • Journal • Preclinical • Review • Allergy • Food Hypersensitivity • Immunology • Transplantation • CCL2 • CCL22 • IFNG • IL10 • IL12A • IL13 • IL1B • IL21 • IL4

Product Theater 3 - Stallergenes Greer (non-CME): Peanut Allergy in Toddlers: A New FDA-Approved Treatment (ACAAI 2024) - "Description This program will review the unmet needs of peanut allergy in the toddler age group and the evidence supporting early intervention for food allergy. The safety and efficacy of oral immunotherapy with Palforzia in toddlers and the changes in biomarkers seen during the Poseidon clinical trial will be discussed."

IO biomarker • Allergy • Food Hypersensitivity • Immunology

Palforzia guideline (BSACI 2024) - No abstract available

Board of Directors approves 5 new drugs, including two anti-tumor drugs [Google translation] (Italian Medicines Agency) - "The AIFA Board of Directors examined and approved in today's session the 43 dossiers submitted by the Pharmaceutical Scientific and Economic Commission...Of these, 5 concern the approval of new drugs: Inaqovi...indicated as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia who are not suitable for standard induction chemotherapy; Litfulo (ritlecitinib), indicated in severe alopecia areata in adults and adolescents aged 12 years and older; Omvoh (mirikizumab), indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, have lost response, or have been intolerant to conventional therapy or a biologic treatment; Opdualag (nivolumab/relatlimab), indicated for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents aged 12 years and older; Palforzia (peanut allergen)..."

Reimbursement • Acute Myelogenous Leukemia • Allergy • Alopecia • Hematological Malignancies • Immunology • Inflammation • Inflammatory Bowel Disease • Leukemia • Melanoma • Oncology • Skin Cancer • Solid Tumor • Ulcerative Colitis

A practical focus on peanut oral immunotherapy. (PubMed, J Food Allergy) - "This milestone is a culmination of years of clinical research and represents a major inflection point for the field because it will have dramatic impacts on allergy practice. In this review, we provide a brief review of the literature as well as practical guidance with concern for the use of U.S. Food and Drug Administration approved peanut OIT as well as shelf-bought products."

Journal • Allergy • Food Hypersensitivity • Immunology

Current state and advances in desensitization for peanut allergy in pediatric age. (PubMed, Pediatr Allergy Immunol) - "In 2020, the Food and Drug Administration and the European Medicines Agency approved Palforzia®, an oral drug for patients aged 4-17 years. Innovative studies are evaluating the use of biological drugs, such as omalizumab or dupilumab, and probiotics, such as Lactobacillus rhamnosus, in monotherapy or associated with oral immunotherapy. Therapy for peanut allergy is constantly evolving, and new perspectives are ongoing to develop."

Journal • Review • Allergy • Food Hypersensitivity • Gastrointestinal Disorder • Immunology • Pediatrics

Omalizumab (Xolair) for food allergy. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Allergy • Food Hypersensitivity • Immunology

Real-world safety experience with Peanut (Arachis hypogaea) Allergen Powder-dnfp in 2,500 peanut-allergic children. (PubMed, Ann Allergy Asthma Immunol) - No abstract available

Journal • Real-world • Real-world evidence • Allergy • Food Hypersensitivity • Immunology

Allergists' Perspectives on Current Food Allergy Therapeutic Options: A Qualitative Study (AAAAI 2024) - "We conducted a qualitative study to document how clinicians manage their patients’ food allergies, as well as their perceptions of available and future treatments, including oral immunotherapy (OIT), sublingual immunotherapy (SLIT), epicutaneous immunotherapy (EPIT), and biologics...Specially, some providers use commercially available foods, while others prescribe Palforzia, the FDA-approved peanut allergy OIT... There is considerable variation in food allergy treatments currently offered to US patients with potential implications for access to appropriate care and the exacerbation of health disparities."

Allergy • Food Hypersensitivity • Immunology

Exploratory immunogenicity outcomes of peanut oral immunotherapy: Findings from the PALISADE trial. (PubMed, Clin Transl Allergy) - P3 | "Specific IgE and IgG4 levels at screening are not correlated with screening or exit DBPCFC results, and are not predictive of clinical response to PTAH. Peanut (Arachis hypogaea) allergen powder-dnfp contains the relevant and immunodominant allergens, inducing immunological changes with the treatment."

Journal • Allergy • Food Hypersensitivity • Immunology

Palforzia for Peanut Allergy: A Narrative Review and Update on a Novel Immunotherapy. (PubMed, Cureus) - "With an increasing prevalence of patient allergies, many questions remain surrounding the optimization of therapies in reaching therapeutic goals. Overall, Palforzia offers a hopeful treatment for peanut-allergic patients to attenuate their immune response while furthering research in related therapies."

Journal • Review • Allergy • Food Hypersensitivity • Immune Modulation • Immunology

Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008) (clinicaltrials.gov) - P3 | N=911 | Completed | Sponsor: Aimmune Therapeutics, Inc. | Enrolling by invitation ➔ Completed | Trial completion date: Dec 2027 ➔ Apr 2023 | Trial primary completion date: Dec 2026 ➔ Apr 2023

Trial completion • Trial completion date • Trial primary completion date • Allergy • Food Hypersensitivity • Immunology

IgE and IgG4 epitopes of the peanut allergens shift following oral immunotherapy. (PubMed, Front Allergy) - "Furthermore, it appears as though the increase in IgG4 is more important to achieve desensitization at the 12-month timepoint than the decrease in IgE. This type of knowledge can be useful in the identification of IgE and IgG4-binding allergen and peptide biomarkers that may indicate desensitization or sustained unresponsiveness of allergic individuals to peanut."

IO biomarker • Journal • Allergy • Food Hypersensitivity • Immunology

Long-term safety and immunologic outcomes of daily oral immunotherapy for peanut allergy. (PubMed, J Allergy Clin Immunol Glob) - "Oral immunotherapy containing peanut (Arachis hypogaea) allergen powder-dnfp (PTAH) (Palforzia [Aimmune Therapeutics, Brisbane, Calif]) for 9 to 12 months resulted in higher tolerated amounts of peanut protein in PTAH-treated individuals aged 4 to 17 years with peanut allergy than in placebo-treated participants...A reduction in median peanut skin prick test wheal diameter was observed (11.50 mm at baseline vs 5.75 mm at year 5). Long-term immunomodulation without any new safety signals was reported with PTAH immunotherapy in the largest safety data set and longest treatment duration for oral immunotherapy published to date."

IO biomarker • Journal • Allergy • Food Hypersensitivity • Gastrointestinal Disorder • Immunology