A new study suggests that a drug already approved for asthma and chronic hives may protect people with severe allergies to foods such as peanuts, eggs, milk and others.
In a first analysis of data from a clinical trial supported by the National Institute of Allergy and Infectious Diseases (NIAID), 165 children and adolescents who received doses of the Xolair drug They were able to consume larger amounts of these foods without having an allergic reaction compared to those who were treated with placebos, said Alkis Togias, chief of NIAID’s division of allergy, asthma and airway biology.
“The main advantage of this drug is that it works with more than one food and that it has been around for about two decades and we know how safe it is, which is pretty good,” Togias said.
The monoclonal antibody omalizumab, marketed as Xolair and developed by Genentech and Novartis, is now available as a treatment for asthma. In clinical trials it was shown that this medication reduces allergic asthma attacks and hives.
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On December 19, NIAID and Genentech announced that the Food and Drug Administration (FDA) would expedite approval of the injectable drug for use against accidental food exposure.
Will health insurance cover it?
Because the drug is FDA-approved for asthma, it can already be prescribed to patients off-label, but doctors said it could be difficult to get medical centers to authorize it and insurers to pay for medications prescribed for asthma. food allergies.
According to Lindsey Mathias, Genentech spokesperson, the monthly cost of Xolair for allergic asthma is approximately $3,663 and the average person suffering from this disease takes the medication for about 10 months.
For chronic spontaneous urticaria, the monthly cost ranges from $1,323 to $2,646, depending on the dose.
Full approval of the drug by the FDA as a food allergy treatment would help with insurers’ problems, according to Togias.
“Insurance companies may still be reluctant even if the FDA grants approval, but it will be more difficult for them if there is an indication for its use that has been authorized,” he said.
The impact of food allergies
About 2% of adults and 4% to 8% of children in the U.S. have food allergies, according to the Department of Agriculture. Anaphylactic shock generated by the consumption of an allergen causes 30,000 emergency room visits, 2,000 hospitalizations and 150 deaths per year.
“About 40% of people who suffer from food allergies are allergic to several foods,” says Togias.
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A number of small studies have shown the drug to be protective, but FDA approval needed to be done. a large scale clinical trial.
According to a description of the trial on the government’s clinicaltrials.gov website, researchers looked for people who were allergic to peanuts, as well as two other foods that can cause adverse reactions, including nuts (cashews, hazelnuts, or walnuts), milk and eggs.
Participants ages 1 to 17 were enrolled, along with three adults ages 18 to 55, all with confirmed allergies to peanuts and at least two other common foods, according to the National Institutes of Health.
At the beginning of the study, participants were administered:
- 600 milligrams of peanut protein, which is equivalent to about two and a half peanuts.
- 1,000 milligrams of egg protein, equivalent to one-fifth of a raw egg.
- Or 600 milligrams of milk protein, equivalent to about one ounce of raw milk.
Participants were also tested with a dose that combined proteins from multiple foods that caused allergic reactions.
“Simplify the lives of doctors and patients”
The potential approval of Xolair for food allergies has been a long time coming, according to Joyce Yu, an expert in pediatric allergy and immunology at Columbia University Vagelos College of Physicians and Surgeons.
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FDA approval would likely “make life simpler for both doctors and patients,” Yu said, adding that she has not used the drug off-label because it is difficult to get permission to do so.
“It would be a helpful option for parents who feel between a rock and a hard place,” Yu said.
Cosby Stone, associate professor of allergy and immunology at Vanderbilt University Medical Center, explained that the drug, which is an artificial antibody, works by stopping a component of the immune system called IgE, which is released in abundance when the body mistakenly identifies a allergen as a parasitic infection.
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A drug that can make allergic children less sensitive to common foods “would be incredibly valuable to children, especially young ones, and their parents, since it is not easy to keep children away from any type of exposure,” says Stone.
“There is already evidence in cohort studies that it tends to protect people from serious reactions,” Stone said. “But I think everyone in our field would be delighted to have evidence from a randomized controlled trial.”
The FDA declined to comment on the drug’s approval status, but NIAID and the two manufacturers recently announced that the FDA had granted priority review for Xolair.
Preliminary analysis showed that , allergies and infectious diseases from Genentech.
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Full results of the trial are expected to be published in a medical journal in late January or February. FDA approval could come as soon as the first quarter of 2024, Togias said.
For Tsai, the trial results have a personal impact, since he is allergic to food and has a son with severe food allergies. “I know firsthand how difficult it is to cope with this condition and live in constant fear of accidental exposure,” he said.
