The U.S. Food and Drug Administration approved Palforzia -- Peanut [Arachis hypogaea] Allergen Powder-dnfp -- to alleviate allergic reactions to accidental peanut exposure, the agency announced late Friday.
Palforzia, a powder manufactured from peanuts, is indicated for initiation in individuals aged 4 to 17 years old with a confirmed peanut allergy. Treatment may be continued in individuals aged 4 years and older.
"When used in conjunction with peanut avoidance, Palforzia provides an FDA-approved treatment option to help reduce the risk of these allergic reactions in children with peanut allergy," Peter Marks, director of the FDA Center for Biologics Evaluation and Research, said in an agency news release.
The FDA notes that Palforzia cannot be used for emergency treatment of allergic reactions. Treatment involves three phases, including initial dose escalation, given on a single day; up-dosing, which involves 11 increasing dose levels over several months; and maintenance.
The initial dose escalation and the first dose of each up-dosing level are administered under the supervision of a health care professional. Once patients have completed all up-dosing levels, they can begin the maintenance phase.
Palforzia is packaged in pull-apart color-coded capsules for the dose escalation and up-dosing levels and is packaged in a sachet for maintenance treatment. The powder from the capsules or sachet is to be mixed with a small amount of food such as applesauce, yogurt, or pudding for the patient to consume.
Approval was based on data from a randomized, double-blind, placebo-controlled study in about 500 peanut-allergic individuals.
In an oral challenge after six months of maintenance treatment, 67.2 percent of individuals who received Palforzia tolerated a 600-mg dose of peanut protein with no more than mild allergic symptoms versus 4 percent of those who received placebo.
In two double-blind, placebo-controlled studies of about 700 peanut-allergic individuals, the most commonly reported side effects with Palforzia included abdominal pain, vomiting, nausea, tingling in the mouth, itching in the mouth and ears, cough, runny nose, throat irritation and tightness, hives, wheezing, and shortness of breath and anaphylaxis.
Approval was granted to Aimmune Therapeutics.
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