[2][6] 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.
[4] The effectiveness of peanut allergen powder is supported by a randomized, double-blind, placebo-controlled study conducted in the US, Canada, and Europe in approximately 500 peanut-allergic individuals.
[6] In December 2018, Aimmune Therapeutics applied Biologics License Application for peanut allergen powder-dnfp to the US Food and Drug Administration.
[6] Peanut allergen powder is only available through specially certified healthcare providers, health care settings, and pharmacies to those who are enrolled in the REMS program.
[10] A 2019 systematic review and meta-analysis of twelve clinical trials consisting of 1041 cases questioned the safety of oral peanut allergen treatment.