The results showed that 67.2% of peanut (Arachis hypogaea) allergen powder recipients tolerated a 600 mg dose of peanut protein in the challenge, compared to 4.0% of placebo recipients.The safety of peanut (Arachis hypogaea) allergen powder was assessed in two double-blind, placebo-controlled studies in approximately 700 peanut-allergic individuals.On 21 December 2018, Aimmune Therapeutics applied Biologics License Application for Peanut (Arachis hypogaea) Allergen Powder-dnfp to the U.S. Food and Drug Administration. On 13 September 2019, the FDA Allergenic Products Advisory Committee decided seven to two in favour of the approval. The final approval was issued on 31 January 2020.On 15 October 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Palforzia, intended for desensitizing children and adolescents to peanut allergy. It was approved for medical use in the European Union in December 2020. Controversy
Although the FDA had decided the approval of Palforzia in 2019,  the Institute for Clinical and Economic Review (ICER) reported that the clinical evidence is still insufficient. A 2019 systematic review and meta-analysis of 12 clinical trials consisting of 1041 cases questioned the safety of oral peanut allergen treatment. The study concluded that the treatments "increase allergic and anaphylactic reactions over avoidance or placebo, despite effectively inducing desensitisation." References
Further reading
The PALISADE Group of Clinical Investigators (November 2018). "AR101 Oral Immunotherapy for Peanut Allergy". New England Journal of Medicine. 379 (21): 1991–2001. doi:10.1056/nejmoa1812856. ISSN 0028-4793. PMID 30449234.
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.