In addition, the Initial Dose Escalation phase and first dose of each Up-Dosing level must only be administered to patients in a certified healthcare setting equipped to monitor patients and to identify and manage anaphylaxis. Patients or their parents or caregivers must also be counseled on the need for the patients to have injectable epinephrine available for immediate use at all times, the need for continued dietary peanut avoidance, and how to recognize the signs and symptoms of anaphylaxis.In January 2020, the FDA approved the drug to Aimmune Therapeutics for mitigating "allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts." It is the first drug approved for peanut allergies. It will not make allergic people to be able to eat normal amounts of peanuts, but will prevent allergies due to accidental eating. History
The effectiveness of peanut (Arachis hypogaea) allergen powder is supported by a randomized, double-blind, placebo-controlled study conducted in the U.S., Canada and Europe in approximately 500 peanut-allergic individuals. Effectiveness was assessed by evaluating the percentage of study participants tolerating an oral challenge with a single 600 mg dose of peanut protein (twice the daily maintenance dose of peanut (Arachis hypogaea) allergen powder) with no more than mild allergic symptoms after six months of maintenance treatment.
Bird JA, Spergel JM, Jones SM,  et al. (2018). "Efficacy and Safety of AR101 in Oral Immunotherapy for Peanut Allergy: Results of ARC001, a Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial". J Allergy Clin Immunol Pract. 6 (2): 476–485.e3. doi:10.1016/j.jaip.2017.09.016. PMID 29092786. Allergenic Products Advisory Committee September 13, 2019 Meeting Transcript (PDF) (Report). U.S. Food and Drug Administration. Dufresne É, Poder TG, Bégin P (October 2019). "The value of oral immunotherapy". Allergy. Wiley. 75 (6): 1291–93. doi:10.1111/all.14072. ISSN 0105-4538. PMID 31579934. External links
"Peanut allergy". Drug Information Portal. U.S. National Library of Medicine.