Go-ahead for first peanut allergy drug
News in Brief . Published: 09 March 2020 . Go-ahead for first peanut allergy drug . Nature Biotechnology volume ?38 ,? page 254 ( 2020 ) Cite this article 775 Accesses 5 Altmetric Metrics details Download PDF The US Food and Drug Administration has approved a first food allergy drug, Aimmune Therapeutics’ Palforzia , for children 4–17 years old with peanut allergies. Palforzia (AR101) consists of peanut ( Arachis hypogaea ) powder capsules to help patients build up tolerance to accidental peanut exposure. Patients start the oral desensitization course with 3-mg daily dose of peanut protein and gradually build up to a 300-mg daily maintenance dose. In a 496-patient pivotal trial, 67% of Palforzia recipients tolerated a 600-mg peanut protein challenge, after 6 months on maintenance treatment, with only mild allergic reactions. Only 4% of placebo recipients tolerated this challenge. Peanut allergy affects around 1 million children in the United States, and accidental exposure can provoke life-threatening anaphylactic shock in some patients, leading Aimmune to predict the drug could exceed $1 billion in global annual sales. But others have their doubts. At over $10,000 per year, the drug’s high cost could deter insurers, and its side effect profile — which mirrors the effects of peanut exposure — could put patients off, say some. While some patients might be tempted by a do-it-yourself peanut desensitization program, clinicians caution against it because of the increased need for epinephrine while on treatment. For Palforzia, treatment initiation and dose escalation must take place in a supervised medical setting. Aimmune’s closest competitor is DBV Technologies. The biotech, headquartered in Paris, first filed its transdermal peanut tolerance patch Viaskin Peanut for approval in 2018, but withdrew this submission months later pending more manufacturing and quality control data. It resubmitted the patch in 2019 and anticipates a decision by August. Aimmune and DBV Technologies are also working on other food allergy desensitization products, including products for egg allergy and milk allergy. Rights and permissions . Reprints and Permissions About this article . Cite this article . Go-ahead for first peanut allergy drug. Nat Biotechnol 38, 254 (2020). https://doi.org/10.1038/s41587-020-0458-7 Download citation Published : 09 March 2020 Issue Date : March 2020 DOI : https://doi.org/10.1038/s41587-020-0458-7 .