WASHINGTON — The Food and Drug Administration has approved the first treatment for children with peanut allergies.
Allergy experts say Aimmune Therapeutics' Palforzia promises to lower the chances that an accidental bite of peanuts causes a severe reaction, but it's not a cure.
Children and teens swallow the peanut powder in tiny but escalating doses to train their bodies to better tolerate peanuts. The peanut powder is emptied from capsules and mixed with a small amount of semisolid food, like applesauce, that the patient then consumes.
Those who do the treatment must continue to avoid peanuts in their diets.
The treatment can cause side effects, possibly serious reactions. So, the FDA says patients and doctors must enroll in a safety program and that each dose increase is given in a certified health facility.
The FDA says kids ages 4 to 17 will be eligible for the treatment if they have a confirmed peanut allergy.
“Peanut allergy affects approximately 1 million children in the U.S. 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, M.D., Ph.D., 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.”
Treatment with Palforzia consists of three phases: initial dose escalation, up-dosing, and maintenance.
The most commonly reported side effects of Palforzia were abdominal pain, vomiting, nausea, tingling in the mouth, itching (including in the mouth and ears), cough, runny nose, throat irritation and tightness, hives, wheezing and shortness of breath and anaphylaxis.
The FDA says the effectiveness of Palforzia is supported by a randomized, double-blind, placebo-controlled study conducted in the U.S., Canada and Europe in approximately 500 peanut-allergic individuals. And, the safety of the treatment was assessed in two double-blind, placebo-controlled studies in approximately 700 peanut-allergic individuals.
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