Omalizumab – the brand Xolair – recently became the first medication approved by the U.S. Food and Drug Administration to reduce allergic reactions in people allergic to one or more foods.
The injectable drug is approved for those ages 1 and older. The FDA approval is based on a clinical trial that found the medication increases the amount of allergens that could be accidentally consumed without a major allergic reaction.
The trial was conducted in children ages 1 to 17 who had allergies to peanuts and at least two of six other foods. It found that 67% of patients who received Xolair shots could tolerate at least 600 milligrams of peanut protein – about 2½ peanuts – without moderate to severe allergic symptoms. This compared to 7% who got placebo shots.
Xolair, developed by manufacturers Genentech and Novartis, averted serious allergic reactions to small amounts of other foods too. About 66% could tolerate the equivalent of two tablespoons of milk, 68% could tolerate about a quarter of an egg, and 41% could tolerate about 3½ cashews.
“For most people, omalizumab will provide a very real level of protection against the accidental exposures that people fear the most,” says Dr. Robert Wood, director of pediatric allergy and immunology at Johns Hopkins Medicine in Baltimore.
Those taking Xolair for food allergies still need to avoid their food allergens and carry an epinephrine auto-injector. In the omalizumab trials at 10 medical centers, the amount of an allergen tolerated varied considerably.
“There were those who had very high levels of protection, and those who had lesser levels of protection,” Wood says. The medication is intended for “day-to-day protection from reaction risk.”
Wood is the co-principal investigator for the Consortium of Food Allergy Research (CoFAR), which led the research. He presented the findings at the 2024 AAAAI allergists’ meeting.
FAQ on Xolair for Food Allergies
Dr. Wood provides Allergic Living with answers to most of the following questions, many of which were raised by Allergic Living readers. Plus, representatives with the drug developers Genentech and Novartis offer additional information.
How Does Xolair Work?
Omalizumab is an “anti-IgE” biologic, or lab-made antibody. People with food allergies produce IgE antibodies to their allergens, which then circulate in their blood. Xolair binds to these IgE antibodies. Over time, this stops the IgE antibodies from binding to mast cells and basophils. Those are immune system cells involved in setting off anaphylaxis.
Does Xolair provide protection for all food allergies?
The FDA approval is based on data from the first stage of the OUtMATCH study, published in late February 2024. Children in the trial had IgE-based allergies to peanuts and at least two other foods: milk, egg, wheat, cashew, hazelnut and walnut.
Because of its anti-IgE effect, Xolair should work similarly for other foods, not just those included in the study, says Dr. Ahmar Iqbal, Genentech’s executive medical director.
“There are 160 food allergens, and we couldn’t design a study with all 160,” he notes. The particular foods were chosen for the study because they are common allergens.
The OUtMATCH study is largely funded by the National Institute of Allergy and Infectious Diseases (NIAID).
What tests are needed before starting the therapy?
For food allergy treatment, you’ll need a blood test to measure total IgE levels. This level, along with body weight, determines your dosing amount and shot frequency.
How does Xolair dosing work for food allergies?
The lowest dose is 75 milligrams every four weeks. The maximum dose is 600 mg every two weeks.
Being on Xolair can be a commitment. The medication currently comes in prefilled syringes that are 75 mg or 150 mg. So you may need more than one injection at a time.
Of 177 children and teens in the trial, 118 were on active treatment (the rest got placebo shots). In the treatment group, about 58% were given omalizumab every two weeks. Their average dose was 300 mg. The other 42% received their shots every four weeks. Their average dose was 225 mg.
Three kids in the trial qualified for the lowest dose of 75 mg every four weeks. The five kids on the highest dose of 600 mg every two weeks were getting four shots every two weeks.
Initial shots are given at the doctor’s office. Many people then will qualify to do home injections. These will soon get easier.
In the coming weeks, Novartis will release a 300-mg prefilled syringe, which will mean fewer injections for some. As well, the drugmaker will also soon introduce an auto-injector for each of the three dosing strengths (75, 150 and 300 mg).
Where do you give a Xolair shot?
When given in a doctor’s office, the shot goes into the upper arm. If you’re administering a prefilled syringe yourself, it’s in the front or middle of the thigh. Your health-care provider will help you with the technique.
For children under age 11, a caregiver needs to provide the shots. For children over age 12, an adult needs either to give or to supervise shot administration.
Are these shots painful?
The shots are subcutaneous – given just under the skin. But they can pinch. Wood says they feel similar to an allergy shot.
How well kids handle the shots depends on their age and temperament. Younger kids may not be as willing to put up with the shots as older kids. Distraction techniques and topical anesthetic can help.
Is Xolair for food allergies OK for adults?
There were three adults in the OUtMATCH study, but their results were not included in the study analysis of the 177 kids ages 1 to 17. The average age of the children in the trial was 7 years old.
Yet, the FDA felt comfortable approving for adults because “the mechanism of food allergy is exactly the same whether you are 6 or 16 or 36,” Wood says.
As well, asthma studies have shown omalizumab works equally well in children, teens and adults, he adds.
I’m worried: Xolair has a warning for anaphylaxis.
After Xolair was approved for asthma in 2003, the FDA required a “black box” warning due to a risk of anaphylaxis from a reaction to the medication.
Anaphylaxis occurs in between 1 in 500 and 1 in 1,000 people receiving Xolair (0.1 to 0.2%). About 60 to 70% of anaphylactic reactions occur during the first three doses.
This is why the first three shots are given in doctor’s offices. After that, if the injections go well, many people can continue taking the shots at home, Wood says.
People with a history of anaphylaxis to foods or medications may be at higher risk of anaphylaxis. Yet none of the 177 participants in the trial had anaphylaxis or any serious reactions to the medication. This was “reassuring,” Wood says.
What about cancer risk?
Safety data from the drugmaker found that cancer was seen in 0.5% of people treated with omalizumab. That compared with 0.2% of control group patients. These studies were mostly in middle-aged patients with asthma, Wood says.
Other research, including a 2022 analysis of studies, has found no evidence of heightened cancer risk. That analysis concluded that studies of “more than 40,000 patients have not found an increased number of tumor cases compared to the general population.”
“There is nothing related to an increased risk of cancer because you’re on this drug,” Wood says.
Will insurance cover Xolair for food allergies?
It remains to be seen, but there is some reason for optimism. The medication is expensive – costs range from $2,900 a month for kids to $5,000 a month for adults, depending on the patient’s dose and dosing frequency.
In addition to treating moderate to severe asthma in children ages 6 and older, omalizumab is also approved to treat chronic spontaneous urticaria and chronic rhinitis with nasal polyps.
“Over the past 20 years, we are pleased that most patients have been covered by insurance for Xolair,” a Genentech spokesperson said in a statement. “We are hopeful to work with payers [insurers] to ensure similar coverage for food allergy patients.”
Patients will need prior authorization from their insurance carrier. Wood says his clinic is just beginning to write prescriptions for Xolair for food allergy, so he will know more in the coming weeks.
“It’s going to be very hard to deny approval,” he says. “The package label does not say you have to have had anaphylaxis before. It says it’s for the treatment of food allergy in ages 1 and above.”
Genentech offers patient assistance programs through Genentech Access Solutions at 866-422-2377. Some patients with commercial health insurance may also quality for the Xolair Co-Pay Program.
Who should consider Xolair for food allergies?
Families will have to weigh costs, convenience, and the risk vs. benefits, Wood says.
“The risk profile is very, very small. It really comes down to whether the family and patient decides that this would be of sufficient benefit to deserve getting injections every 2 weeks or every 4 weeks,” Wood says. “That will be a pretty individualized decision.”
Patients will need to consider “their risk of having reactions, their history of past reactions, and their level of stress and anxiety surrounding their food allergies,” he says.
Will the drugmakers seek approval in the UK, Canada?
“There are currently no plans to seek regulatory approvals of Xolair in food allergy in markets outside of the U.S.,” according to a Novartis spokesperson.
She notes that the OUtMATCH study was conducted only in the U.S. and sponsored by the National Institutes of Health. It was aimed “at evaluating the use of Xolair in food allergy within the U.S. This study has been designed based on feedback from the U.S. FDA,” she said.
How long do you take Xolair before protection starts?
“We know that 16 weeks was adequate. Shorter periods might work but this has not been studied sufficiently to say,” Wood says.
How do you know if Xolair is providing protection?
The only way to know for certain is to do an oral food challenge with the allergenic food. There currently isn’t a blood test or other test that can predict how much of a food someone could tolerate after being on the medication.
How do you know how much allergen you can eat?
Wood says it’s the same answer – a food challenge is the only way to know how much of a food you can eat before reacting. This is why people taking Xolair for food allergies need to practice continued avoidance.
Some in the study were able to tolerate remarkable amounts of allergens. In the trial, the cumulative dose, or total amount consumed over the course of several hours during food challenges, was 1,044 mg of peanut. That meant the 67% who met the study’s primary endpoints consumed the equivalent of over 4 peanuts.
However, beyond that trial endpoint, the average that OUtMATCH participants could consume was 16 peanuts. And 44% could consume 25 peanuts.
“Many patients can actually eat larger amounts of the food they’re allergic to,” Wood says. “But the initial approach will be very much following the FDA package label,” which is for protection from accidental exposures.
While many could consume more than the thresholds set by researchers, 33% of children did not meet the primary endpoints.
Even so, many of them increased the amount of allergen that they could safely consume. For example, a child who went from reacting to 3 mg of peanut to 300 mg (about one peanut) would not have met the primary endpoint. Yet, that child would still have significantly more protection than before.
“We think this person would have gotten a big benefit, although they would not qualify as a responder,” Wood says.
Only about 14% didn’t reach 30 mg of peanut (about 1/10th of a peanut), Wood says. The OUtMATCH team is working on learning why some people don’t respond, and whether there are tests to identify ahead of time who might not.
What is the Xolair research with OIT?
The FDA approved Xolair as a monotherapy for food allergy – that is, Xolair alone.
But there’s a lot of interest in whether Xolair could help to speed up oral immunotherapy (OIT) by reducing the build-up phase. During OIT, patients eat progressively larger amounts of their food allergen over the course of months.
Subsequent phases of the OUtMATCH research will compare Xolair as a monotherapy with using Xolair to facilitate multi-allergen OIT. All patients will receive Xolair initially.
Then, some will start on OIT to their food allergens while receiving placebo Xolair. Another group will continue on Xolair, but will receive placebo OIT. Stage 2 of the trial, which lasts about a year, is expected to wrap up in August 2024.
This will provide “a head-to-head comparison of anti-IgE versus OIT in terms of how much protection you may have,” Wood says.
Once you start Xolair, do you continue on it indefinitely?
The current FDA approval is for desensitization only, so the patient stays on the drug to maintain that. If you stop Xolair, your IgE antibody levels rebound and you’ll lose protection in about one to two months.
Wood notes that patients and families may also choose to use Xolair for a specific period of life, perhaps one seen as being riskier.
However, the research into Xolair’s potential is continuing. Stage 3 of the OUtMATCH study is investigating the possibility that patients could be treated with Xolair, and afterward maintain desensitization by eating allergenic foods.
In Stage 3, patients with multiple food allergies who have taken Xolair for at least 24 to 28 weeks will undergo food challenges. Those who pass a food challenge by eating at least 600 mg of their allergenic food without a significant reaction can start eating a set amount of the food in their diet. In such a case, they would no longer take the medication.
“Stage 3 will be of great interest as it will study the possibility of actually eating the allergic foods after Xolair treatment,” Wood says.
Can you take Xolair alongside Dupixent?
For those with both EoE (eosinophilic esophagitis) as well as IgE food allergies, Wood says there isn’t a reason to believe you couldn’t. Dupilumab (the brand Dupixent) blocks both IL-4 and IL-13 signaling. It’s approved to treat EoE in people ages 1 and older.
“We don’t envision a risk of doing two different biologics,” Wood says.
Taking Xolair and Dupixent hasn’t been specifically studied. So it’s best to discuss it with your allergist or other specialist.
What were the most common adverse effects?
The most common adverse effects from Xolair were injection site reaction and fever. They were consistent with what has been seen in other studies of Xolair for other conditions.
What are the ingredients in a Xolair shot?
Xolair current product information lists the following ingredients.
Active ingredient: omalizumab
Inactive ingredients:
– In the prefilled syringe or auto-injector: arginine hydrochloride, histidine, L-histidine hydrochloride monohydrate, and polysorbate 20.
– In the vial: histidine, L-histidine hydrochloride monohydrate, polysorbate 20 and sucrose.
If you have latex allergy: discuss with your specialist. The needle cap on the Xolair prefilled syringe does contain natural rubber latex.
Related Reading:
Xolair for Food Allergies: Full Study Unveiled to Allergists
Palforzia OIT Sees Maturing of Immune System over Time
Dr. Marc Rothenberg on: Dupilumab’s Approval for EoE Patients
