FDA Approves the First Drug for Treatment of Peanut Allergy in Children
The US Food and Drug Administration has approved Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] for the treatment of allergic reactions that could occur with accidental exposure to peanuts.
Palforzia can be initiated in patients aged 4 to 17 years old with confirmed diagnosis of peanut allergy. Along with treatment, patients must continue to avoid peanut exposure.
Treatment with Palforzia consists of 3 stages. The initial dose escalation phase occurs over a single day. The up-dosing phase consists of 11 increasing dose levels given to the patient over several months. The initial dose escalation and first dose of each up-dosing doses are administered by healthcare professionals. When the patient completes all up-dosing levels, they begin the daily maintenance dose stage.
The effectiveness of the new option was evaluated in a randomized, double-blind, placebo-controlled study involving approximately 500 peanut-allergic individuals. Overall, 67.2% of those given Palforzia tolerated 600 mg doses of peanut protein compared with 4.0% of those in the placebo group.
The safety of the new option was evaluated in 2 double-blind, placebo-controlled studies involving approximately 700 peanut-allergic patients. The most commonly reported adverse effects were abdominal pain, vomiting, nausea, tingling in the mouth, itching, cough, runny nose, throat irritation, hives, wheezing, shortness of breath, and anaphylaxis.
FDA approves first drug for treatment of peanut allergy for children [press release]. Silver Springs, MD: US Food and Drug Administration; January 31, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-treatment-peanut-allergy-children?utm_campaign=013120_PR_FDA%20approves%20first%20drug%20for%20treatment%20of%20peanut%20allergy%20for%20children.