For people with multiple food allergies, new research suggests that a drug already approved for asthma and chronic urticaria may protect against severe reactions to peanuts, eggs, milk and other foods.
In an early analysis of data from a National Institute of Allergy and Infectious Diseases-sponsored clinical trial, 165 children and adolescents who received Xolair by injection were able to consume larger portions of food without causing an allergic reaction compared to children and adolescents who received a placebo, Dr. Alkis Togias, NIAID allergy specialist , director of the Asthma and Respiratory Biology Branch, said.
The biggest advantage of this drug is that it covers more than one food and that it’s 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 to treat asthma. The drug was shown to reduce allergic asthma attacks and hives in clinical trials.
On Dec. 19, NIAID and Genentech announced that the Food and Drug Administration accelerated approval of an injectable drug for use against accidental food exposure.
Because the drug is FDA-approved to treat asthma, it can already be prescribed to patients off-label, but doctors said it could be difficult to get medical centers to figure it out and get insurance companies to pay for prescriptions for food allergies.
The monthly price of Xolair to treat allergic asthma is about $3,663, and the average patient with the condition takes the drug for about 10 months, according to Genentech spokeswoman Lindsey Mathias. Monthly costs for chronic spontaneous urticaria chronic urticaria range from $1,323 to $2,646 depending on dose.
Full FDA approval for the drug to treat food allergies would help with insurance issues, Togias said.
Insurance companies can still refuse even if FDA approval is granted, it’s harder for them to do so if there’s an approved indication, he said.
According to the USDA, about 2 percent of adults and 4 to 8 percent of children in the United States have food allergies. Anaphylactic shock caused by allergen consumption results in 30,000 emergency room visits, 2,000 hospitalizations, and 150 deaths each year.
About 40% of people with food allergies are allergic to multiple foods, Togias said.
There have been numerous small studies that have found the drug to be protective, but a large clinical trial is needed to gain FDA approval.
In a description of the study on Clinicaltrials.gov, researchers looked for people who were allergic to peanuts and two other foods that can cause bad reactions, including nuts (cashews, hazelnuts or walnuts), milk and eggs. Participants ages 1 to 17 were included, along with three adults ages 18 to 55, all of whom had 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 given:
600 mg of peanut protein, which is equivalent to about two and a half peanuts.
1000 mg of egg protein, equivalent to one-fifth of a raw egg.
Or 600 mg of milk protein, which is equivalent to about an ounce of unboiled milk.
Participants were also tested with a dose that combined proteins from several foods that cause allergic reactions.
Xolair’s potential approval for food allergies has been a long shot, said Dr. Joyce Yu, a pediatric allergy and immunology specialist at Columbia University’s Vagelos College of Physicians and Surgeons.
FDA approval would likely make life simpler for both doctors and patients, said Yu, who added that he has not used the drug aberrantly because it is difficult to obtain approval.
This would be a useful option for parents who feel stuck between a rock and a hard place, Yu said.
Dr. Cosby Stone, assistant professor of allergy and immunology at Vanderbilt University Medical Center, explained that the drug, which is a man-made antibody, works by suppressing a component of the immune system called IgE, which is released in abundance when the body mistakenly identifies an allergen as a parasitic infection.
A drug that could make allergic children less sensitive to common foods would be incredibly valuable to children, especially toddlers, and their parents because it’s not easy to keep children away from all kinds of exposure, Stone said.
There is already evidence from cohort studies showing 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 drug’s approval status, but NIAID and two drugmakers recently announced that the FDA had granted Xolair priority review.
A preliminary analysis showed that Xolair significantly increased the amount of peanut as a primary target and the amount of milk, eggs and cashew needed to cause an allergic reaction in children and adolescents with food allergies, Dr. Larry Tsai, director of respiratory, allergy and infectious diseases. product development at Genentech, said in an email.
The full study results are expected to be published in a medical journal in late January or February.
FDA approval could happen as soon as the first quarter of 2024, Togias said.
For Tsai, the test results are personal because she has food allergies and also has a child with a severe food allergy.
“I know firsthand how challenging it is to survive this condition and live in constant fear of accidental exposure,” Tsai said.
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