Aimmune Therapeutics, Inc. announced it will present important new long-term safety, efficacy and immunological data from ARC004, an open-label, rollover study of the pivotal PALISADE trial of PALFORZIA™ and data on patient-reported treatment satisfaction from the European phase 3 ARTEMIS trial of PALFORZIA. In addition, insights from the PAPRIQUA study about the psychosocial burden of peanut allergy on children and their caregivers will be presented. These data will be presented at the European Academy of Allergy and Clinical Immunology Digital Congress to be held from June 6, 2020 to June 8, 2020. PALFORZIA Clinical Trial Data: 1230: Sharma et al., Treatment Satisfaction with AR101 Oral Immunotherapy for Peanut Allergy in a European Paediatric Population. 1393: Fernández-Rivas et al., PALISADE Follow-On Study (ARC004): Longer-Term Outcomes with AR101 Oral Immunotherapy for Peanut Allergy. Peanut Allergy Data: 243: Acaster et al., Peanut Allergy impact on PRoductivity and QUAlity of life (PAPRIQUA): The Psychosocial Impact of Peanut Allergy in Children and Caregivers. Additional Data Involving PALFORZIA: 1343: Wambre et al., Baseline characteristics of peanut-allergic individuals during the dupilumab as adjunct to AR101 clinical trial. PALFORZIA (previously known as AR101) is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. PALFORZIA is approved for use in the United States in patients with a confirmed diagnosis of peanut allergy. In Europe, Aimmune has a marketing authorization application for AR101 (PALFORZIA) under review with the European Medicines Agency. INDICATION: PALFORZIA is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. PALFORZIA is approved for use in patients with a confirmed diagnosis of peanut allergy. Initial Dose Escalation may be administered to patients aged 4 through 17 years. Up-Dosing and Maintenance may be continued in patients 4 years of age and older. PALFORZIA is to be used in conjunction with a peanut-avoidant diet. Limitations of Use: Not indicated for the emergency treatment of allergic reactions, including anaphylaxis. Boxed WARNING: PALFORZIA can cause anaphylaxis, which may be life threatening and can occur at any time during PALFORZIA therapy. Prescribe injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use. Do not administer PALFORZIA to patients with uncontrolled asthma. Dose modifications may be necessary following an anaphylactic reaction. Observe patients during and after administration of the Initial Dose Escalation and the first dose of each Up-Dosing level, for at least 60 minutes. PALFORZIA is available only through a restricted program called the PALFORZIA REMS. Contraindications: PALFORZIA is contraindicated in patients with uncontrolled asthma, or with a history of eosinophilic esophagitis and other eosinophilic gastrointestinal disease. Warnings and Precautions: PALFORZIA can cause anaphylaxis, which may be life threatening. PALFORZIA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy called the PALFORZIA REMS because of the risk of anaphylaxis. Only prescribers, healthcare settings, pharmacies, and patients certified and enrolled in the REMS Program can prescribe, receive, dispense or administer PALFORZIA. Anaphylaxis has been reported during all phases of PALFORZIA dosing, including Maintenance and in subjects who have undergone recommended Up-Dosing and dose modification procedures. Do not initiate PALFORZIA treatment in a patient who has had severe or life-threatening anaphylaxis within the previous 60 days. PALFORZIA may not be suitable for patients with certain medical conditions that may reduce the ability to survive anaphylaxis, including but not limited to markedly compromised lung function, severe mast cell disorder, or cardiovascular disease. In addition, PALFORZIA may not be suitable for patients taking medications that can inhibit or potentiate the effects of epinephrine. All Initial Dose Escalation doses and the first dose of each Up-Dosing level must be administered in a certified health care setting. Patients may be more likely to experience allergic reactions following PALFORZIA administration in the presenceof cofactors such as exercise, hot water exposure, intercurrent illness or fasting. Other potential cofactors may include menstruation, sleep deprivation, nonsteroidal anti-inflammatory drug use, or uncontrolled asthma. Patients should be proactively counseled about the potential for the increased risk of anaphylaxis in the presence of these cofactors. If possible, adjust the time of dosing to avoid these cofactors. If it is not possible to avoid these cofactors, consider withholding PALFORZIA temporarily. Asthma: Uncontrolled asthma is a risk factor for a serious outcome, including death, in anaphylaxis. Ensure patients with asthma have their asthma under control prior to initiation of PALFORZIA. PALFORZIA should be temporarily withheld if the patient is experiencing an acute asthma exacerbation. Following resolution of the exacerbation, resumption of PALFORZIA should be undertaken cautiously. Re-evaluate patients who have recurrent asthma exacerbations and consider discontinuation of PALFORZIA. Eosinophilic Gastrointestinal Disease: Discontinue PALFORZIA and consider a diagnosis of eosinophilic esophagitis in patients who experience severe or persistent gastrointestinal symptoms, including dysphagia, vomiting, nausea, gastroesophageal reflux, chest pain, or abdominal pain. Gastrointestinal Adverse Reactions: Gastrointestinal adverse reactions were commonly reported in PALFORZIA-treated subjects, and dose modification should be considered for patients who report these reactions. For severe or persistent gastrointestinal symptoms consider a diagnosis of eosinophilic esophagitis. Adverse reactions: The most common adverse events reported in subjects treated with PALFORZIA (incidence = 5% and = 5% than placebo) are abdominal pain, vomiting, nausea, oral pruritus, oral paresthesia, throat irritation, cough, rhinorrhea, sneezing, throat tightness, wheezing, dyspnea, pruritus, urticaria, anaphylactic reaction, and ear pruritus.