FDA approves drug that combats food allergies
Xolair, which suppresses antibodies that provoke inflammation, offers new option
When 8-month-old Liam Wang ate scrambled eggs for the first time, he broke out in hives — surprising his parents, Ann Marqueling and Kevin Wang, who have two older children who do not have egg allergies.
They took Liam to an allergist and discovered that in addition to eggs, he was also allergic to peanuts, walnuts and cashews. And the skin prick test indicated the allergies could be severe.
Since then, the Palo Alto parents have had to do what they call “advanced reconnaissance” anytime Liam, now 5, is around food: They carefully read ingredient labels before bringing any food into the home. If Liam is heading to a friend’s house, they ask that the hosts not have peanuts or eggs around. They carry an EpiPen, and stay close during Liam’s play dates in case he’s accidentally exposed to one of those allergens.
Liam has never had a severe reaction to an accidental exposure, but the risk is always on his parents’ minds.
A newly approved drug has the potential to offer some relief for Liam, his family and millions of others like them who worry that accidental exposure to even small amounts of peanuts or other foods can trigger a potentially life-threatening reaction. Until now, those like Liam mostly had two options: scrupulously avoid the food, or carry an EpiPen. Most do both.
The drug, Xolair, could offer an additional option. It is an injectable medication that lessens the severity of allergic reactions to food, when taken every few weeks before exposure to small amounts of food. The Food and Drug Administration approved it this month for adults and children 1 or older who are allergic to one or more foods.
The medication, made by Genentech and Novartis, is the first FDA-approved drug for people with multiple food allergies. A
different drug, Palforzie, treats peanut allergies, but not allergies to any other foods. Xolair has also been used for years to treat asthma attacks triggered by allergies, but this is the first time regulators have approved its use for food allergies.
Xolair, also known as omalizumab, is not a cure, and people who are allergic to certain foods should still avoid them, the FDA cautioned.
But it holds promise as a therapy that could help patients and their families live their lives more freely, said Dr. Sharon Chinthrajah, a Stanford University allergist who led the clinical trial that the FDA reviewed when deciding whether to approve the drug.
In people with food allergies, the immune system thinks certain food proteins are dangerous, and produces antibodies to protect against the perceived threat. This triggers an inflammatory response and leads to symptoms of an allergic reaction, such as difficulty breathing, hives or anaphylaxis. Xolair takes these antibodies out of circulation and therefore blunts the severity of the inflammatory response.
“This offers a layer of protection when they go out, to live their life as normally as possible,” Chinthrajah said.
Accidental exposures can happen easily. At a bakery, a donut with nut sprinkles could be next to a nut-free donut. At an ice cream shop, a scoop dipped in nut toppings may later touch a nut-free item. Chinthrajah once had a patient with a walnut allergy who reacted to pasta with marinara sauce at a restaurant because the sauce unexpectedly contained the nuts.
“These are the types of scenarios our families encounter, even when they’re so very careful,”
said Chinthrajah, an associate professor of medicine and acting director of Stanford’s Sean N. Parker Center for Allergy and Asthma Research. “This therapy can protect them from those types of instances.”
The results of the trial, published Sunday in the New England Journal of Medicine, found that patients who received Xolair were more likely to be able to tolerate foods they’re allergic to compared to people who got the placebo.
About 67% of patients who received Xolair could tolerate eating 600 milligrams of peanut protein, the equivalent of two to
three peanuts, compared to 7% of the placebo group, the study found. About 80% of people who received Xolair could eat small amounts of at least one allergytriggering food without having an allergic reaction.
The trial included 177 patients, all children 1 year and older, and Xolair was given to two-thirds of them (the other third got a placebo shot) every two or four weeks, depending on body weight, over a period of four months. Participants underwent “food challenges,” eating small amounts of foods they were allergic to — under close medical supervision — and researchers measured their
reactions.
The results are from the first phase of the ongoing study, and researchers are continuing the work to try to answer other questions — such as how long someone can be on Xolair, and whether it’s safe to combine it with other therapies.
Liam was a participant in the study, but he and his parents don’t know whether he received Xolair or a placebo because the trial was double blind. Still, the prospect of a medication being able to lessen a severe reaction helps quell some anxiety.
“Parents with children who have these severe allergies to
foods will be able to rest easier because now there’s potentially another avenue to further mitigate the risk,” Kevin Wang said.
Marqueling and Kevin Wang, both Stanford dermatologists, plan to ask Liam’s allergist if Xolair would be a good option for him. The study’s early results bring some hope that the medication may be able to grant Liam more freedom — or as Kevin Wang put it, “being able to participate in activities without Mom and Dad hovering at all times to check on nuts.”