In a new, groundbreaking development in the fight against food allergies, the Food and Drug Administration approved the first treatment for children with peanut allergies on Friday.
"Peanut allergy affects approximately 1 million children in the U.S. and only 1 out of 5 of these children will outgrow their allergy," said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research in a news release. "Because there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions."
The drug, called Palforzia, is not a cure but still marks a step forward in reducing allergic reactions for kids ages 4 through 17, who have already been diagnosed with peanut allergies.
Marks noted that even when avoiding peanuts, inadvertent exposure can still happen and that's what this drug aims to treat. He explained, "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.”
The FDA acknowledges that peanut allergies are unpredictable and severe reactions can occur from even the smallest trace of peanuts.
The Palforzia pill is administered in three phases and is taken over time, but cannot be used in an emergency situation in the way that a treatment like an EpiPen is used.
The first phase, called initial dose escalation, is consumed on a single day under the supervision of a medical professional, while up-dosing, the second phase, takes place over several months and involves 11 increased dose levels. The first dose in up-dosing would be given under a medical professional's supervision as well, just to manage any potential severe allergic reactions. After that, the drug can be taken at home, as long as everything goes smoothly. Once the 11 doses in the second phase are completed, the third and final maintenance dose would then be administered daily.
The drug itself is a powder made from peanuts that comes in color-coded capsules for the first two phases. In the maintenance phase, the drug comes in a sachet. The powder can be mixed with semi-soft foods such as applesauce and yogurt before a child consumes it.
The FDA tested both the effectiveness and safety of the new drug in multiple double-blind, placebo-controlled studies with approximately 500 individuals with peanut allergies. Based on those studies, the potential side effects of Palforzia include abdominal pain, itching, tingling in the mouth, nausea, vomiting, cough, runny nose, throat irritation, tightness, hives, wheezing, shortness of breath and anaphylaxis.
While peanut allergy symptoms can vary among individuals, the most extreme response is anaphylaxis. Anaphylaxis is a life-threatening reaction that can cause constriction of the airways, throat swelling, loss of consciousness, and a severe drop in blood pressure, according to the Mayo Clinic.
Doctors who administer Palforzia are required by the FDA to be educated on the risks of anaphylaxis, and the drug will only be available through certified healthcare providers, health care settings and pharmacies to patients enrolled in a Risk Evaluation and Mitigation Strategy (REMS) program, or whose parents or caregivers are.
According to the American College of Allergy, Asthma and Immunology, peanut allergies are the most common food allergy in the U.S. and a 2017 study found peanut allergies increased by 21 percent since 2010. With peanut allergies on the rise, this type of treatment can help prevent more serious reactions.