For people with multiple food allergies, new research suggests that a drug already approved for asthma and chronic hives may protect against severe reactions to peanuts, eggs, milk and other foods.
In an early analysis of data from a clinical trial backed by the National Institute of Allergy and Infectious Diseases, 165 children and adolescents who received injections of the drug Xolair were able to consume higher doses of the foods without triggering an allergic reaction, compared to those who treated with placebos, Dr. Alkis Togias, chief of the allergy, asthma and airway biology branch at NIAID, said.
“The major advantage of this medication is that it will cover more than one food and that it has been around for about two decades and we know its safety profile, which is pretty good,” Togias said.
The monoclonal antibody omalizumab, marketed as Xolair and developed by Genentech and Novartis, is already available as a treatment for asthma. The medication was shown to reduce allergic asthma attacks and hives in clinical trials.
On Dec. 19, the NIAID and Genentech announced that the Food and Drug Administration was fast-tracking the approval of the injectable medication to be used against accidental exposure to foods.
Because the drug has FDA approval for asthma, it can already be prescribed off-label to patients, but doctors said that it could be difficult to get medical centers to clear it and to get insurers to pay for a prescription for food allergies.
The monthly cost for Xolair for allergic asthma is approximately $3,663 and the average person with the condition takes the medication for about 10 months, according to Genentech spokesperson Lindsey Mathias. For chronic spontaneous urticaria — chronic hives — the monthly cost ranges from $1,323 to $2,646, depending on the dosage.
Full approval of the medication by the FDA as a treatment for food allergies would help with insurance issues, Togias said.
“Insurance companies may still balk even when FDA approval is granted, it will be more difficult for them to do so if there is an approved indication,” he said.
About 2% of adults and between 4% and 8% of children in the U.S. have food allergies, according to the USDA. Anaphylactic shock brought on by consumption of an allergen results in 30,000 emergency room visits, 2,000 hospitalizations and 150 deaths each year.
“About 40% of people who have food allergies are allergic to multiple foods,” Togias said.
There has been a host of small studies that found the medication to be protective, but to get FDA approval there needed to be a large clinical trial.
In a description of the trial on clinicaltrials.gov, researchers sought people with an allergy to peanuts, plus two other foods that can cause bad reactions , such as tree nuts (cashew, hazelnut or walnut), milk and eggs. Participants ages 1 to 17 were enrolled, along with three adults ages 18 to 55, all who had confirmed allergy to peanut and at least two other common foods, according to the National Institutes of Health.
Early in the study, participants were given:
- 600 mg of peanut protein, which is equivalent to about two-and-a-half peanuts.
- 1,000 mg of egg protein, the equivalent of one-fifth of a raw egg.
- Or 600 mg of milk protein, equivalent to about an ounce of uncooked milk.
The participants also were tested with a dose that combined proteins from multiple foods that caused allergic reactions.
The possible approval of Xolair for food allergies has been a long time coming, said Dr. Joyce Yu, an expert in pediatric allergy and immunology at the Columbia University's Vagelos College of Physicians and Surgeons.
FDA approval would quite possibly “make life simpler for both doctors and patients,” said Yu, who added that she has not used the medication off-label because it’s difficult to get permission for it.
“This would be a helpful option for parents who feel stuck between a rock and a hard place,” Yu said.
Dr. Cosby Stone, an assistant professor in allergy and immunology at the Vanderbilt University Medical Center, explained that the medication, which is a manmade antibody, works by tamping down a component of the immune system called IgE, which gets released in abundance when the body mistakenly identifies an allergen as a parasitic infection.
A drug that can make allergic children less sensitive to common foods “would be incredibly valuable to children, especially toddlers, and their parents since it’s not easy to keep kids away from any type of exposure,” Stone said.
“There’s already evidence out there in cohort studies that show that it tends to protect people from severe reactions,” Stone said. “But I think everyone in our field would be thrilled to have evidence from a randomized controlled trial.”
The FDA declined to comment on the status of the medication’s approval, but NIAID and the two drugmakers announced recently that the FDA had granted priority review for Xolair.
The preliminary analysis showed that Xolair significantly increased the amount of peanut — the primary goal — and milk, eggs and cashew it took to cause an allergic reaction in children and adolescents with food allergies, Dr. Larry Tsai, global head of respiratory, allergy and infectious disease product development at Genentech, said in an email.
The full trial findings are expected to be published in a medical journal in late January or February.
The FDA approval could happen as soon as the first quarter of 2024, Togias said.
For Tsai, the trial findings are personal, since he has food allergies and also has a child with severe food allergies.
“I know firsthand how challenging it is to cope with this condition and to live in continued fear of an accidental exposure,” Tsai said.