FDA Approves First Treatment for Peanut Allergy—But It's for Kids Only
It doesn't prevent or cure this common food allergy.
For the millions of people with peanut allergies, some life-changing news from the U.S. Food and Drug Administration (FDA). On January 31, the agency announced the approval of the drug Palforzia to mitigate allergic reactions that may occur with accidental exposure to peanuts. The fact that it’s the first FDA-approved treatment ever for food allergies makes it even more of a big deal.
Palforzia is approved for children and teens ages four through 17 who have a peanut-allergy diagnosis. Peanut allergies, the most common type of food allergy in children, have increased by 21% since 2010, according to national survey data presented at a 2017 allergy meeting.
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Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement released by the agency that peanut allergy affects approximately one million children in the U.S., and only one in five of them will outgrow their allergy.
“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,” Dr. Marks said.
It’s a big moment, because peanut allergies can be life-threatening and even minute exposures can be deadly. “Those who are most allergic must spend go to great lengths to avoid any exposure to peanuts,” Omid Mehdizadeh, MD, otolaryngologist (ENT) and laryngologist at Providence Saint John’s Health Center in Santa Monica, Calif., tells Health.
Palforzia doesn’t “cure” a peanut allergy and isn’t indicated for the emergency treatment of allergic reactions, including anaphylaxis, and it must be used alongside a peanut-avoidant diet. But immunotherapy with the drug may desensitize patients and turn a potentially life-threatening reaction into one that may not be as dangerous, Dr. Mehdizadeh explains.
So how does it work? Well, it’s not a quick fix. Palforzia, which is a powder made from peanuts, decreases the frequency and severity of an allergic reaction via immunotherapy. This involves exposing a person to tiny but increasing doses of peanuts (or whatever they are allergic to) over a period of time. “The child's immune system is desensitized to peanuts by exposing him or her to incrementally increasing amounts of peanut allergen via the medication over time,” Dr. Mehdizadeh says.
According to the prescribing information provided by the FDA, Palforzia treatment consists of three phases: initial dose escalation, up-dosing, and maintenance. The initial dose escalation takes place over a single day, involving five gradually increasing doses of the drug. Up-dosing consists of 11 increasing dose levels across several months. Both phases take place under supervision at a health care facility. The final maintenance phase requires absolute adherence to the daily dose for the drug to work.
Peanut allergy tends to persist into adulthood—only about 20% of kids eventually outgrow their allergy, says the American College of Allergy, Asthma & Immunology. So far, though, Palforzia is only FDA-approved for children, and there’s been no official statement on whether it might be approved for adults in the future. “Immunotherapy works for adults as well, but children may be more prone to accidental exposures,” Dr. Mehdizadeh says.
In some cases the drug may have to be taken over prolonged periods or even indefinitely, to provide protection. “The required duration varies from person to person, and some will require maintenance for longer than others,” Dr. Mehdizadeh says.
Palforzia doesn’t come cheap—the list price is $890 per month, or about $11,000 per year. However, a co-pay program and a patient assistance program will be available for eligible patients, per a statement released by Aimmune Therapeutics, the company that makes the drug.
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