FDA clears 1st treatment for peanut allergy in children
Parents with children who have peanut allergies have a new treatment option to help reduce the risk of allergic reactions. The Food and Drug Administration has cleared Aimmune Therapeutic's Palforzia (peanut allergen powder-dnfp).
The product is indicated to mitigate allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts. Treatment with Palforzia may be used in patients ages 4 through 17 years old with a confirmed diagnosis of peanut allergy and may be continued in individuals 4 years of age and older. Those who take Palforzia must continue to avoid peanuts in their diets.
"Peanut allergy affects approximately 1 million children in the United States and only 1-out-of-5 of these children will outgrow their allergy. Because there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions," said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. "Even with strict avoidance, inadvertent exposures can and do occur. 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."
Palforzia is a powder that is manufactured from peanuts and packaged in pull-apart color-coded capsules for dose escalation and up-dosing, and in a sachet for maintenance treatment. The powder is emptied from the capsules or sachet and mixed with a small amount of semisolid food — such as applesauce, yogurt, or pudding — that is then eaten.