Aimmune Therapeutics, Inc. announced that the first patients in the United States are being treated with PALFORZIA [Peanut (Arachis hypogaea) Allergen Powder-dnfp], the first approved treatment for peanut allergy. Following the release of the medication lots by the U.S. Food and Drug Administration (FDA), specialty pharmacies are shipping PALFORZIA initial dosing kits to allergists for in-office administration to their peanut-allergic patients aged 4 through 17 years with a confirmed diagnosis of peanut allergy. PALFORZIA may only be administered to patients by allergists and allergy practices that have been certified under the Risk Evaluation and Mitigation Strategy (REMS) program. A list of certified allergists who are able to provide PALFORZIA treatment may be viewed at www.PALFORZIAREMS.com. PALFORZIA was approved by the U.S. Food and Drug Administration on January 31, 2020, as 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. PALFORZIA is not indicated for the emergency treatment of allergic reactions, including anaphylaxis. Dispensing of PALFORZIA is limited to contracted pharmacies that will be certified in the PALFORZIA REMS Program. PALFORZIA is available only through a Risk Evaluation and Mitigation Strategy (REMS). Requirements of the REMS include: the prescribing physician and patient must be enrolled in the REMS prior to initiation of treatment; the initial dose escalation and the first dose of each up-dosing level must be administered in a certified healthcare setting; epinephrine must always be immediately available to patients; and pharmacies/distributors must be certified with the REMS and dispense PALFORZIA only to certified healthcare settings or to patients who are enrolled in the REMS. Consistent with approved immunotherapies indicated to treat allergic conditions, the Prescribing Information for PALFORZIA contains a boxed warning. Aimmune will provide resources to patients and families who, upon consultation with their physician, wish to seek treatment with PALFORZIA. These resources will include educational materials, a dedicated call center, a co-pay program for eligible patients, and a Patient Assistance Program to provide PALFORZIA at no cost to eligible patients.