For people with many 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 supported by the National Institute of Allergy and Infectious Diseases, 165 children and teens who received injections of the drug Were able to consume higher doses. were treated with a placebo, said Dr. Alkis Togias, chief of the allergy, asthma and airway biology branch at NIAID.
The main advantage of this drug is that it will cover more than one food item and it has been around for almost two decades and we know its safety profile, which is quite good, Togias said.
The monoclonal antibody omalizumab, marketed as Exolair and developed by Genentech and Novartis, is already available as a treatment for asthma. The drug was shown to reduce allergic asthma attacks and hives in clinical trials.
On December 19, NIAID and Genentech announced that the Food and Drug Administration was accelerating approval of an injectable drug to be used against accidental exposure to foods.
Because the drug has FDA approval for asthma, it can already be prescribed to patients off-label, but doctors said it is difficult to get it approved by medical centers and insurers to pay for prescriptions for food allergies. It may be difficult to do.
According to Genentech spokesperson Lindsay Mathias, the monthly cost of Xolair for allergic asthma is about $3,663 and the average person with the condition takes the drug for about 10 months. Monthly costs for chronic spontaneous urticaria range from $1,323 to $2,646, depending on the dosage.
Togias said full approval of the drug by the FDA as a food allergy treatment would help with insurance issues.
While insurance companies may back out even if they get FDA approval, it would be more difficult for them to do so if there was an approved indication, he said.
According to the USDA, about 2% of adults and 4% to 8% of children in the US have food allergies. Anaphylactic shock from allergen ingestion 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.
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There have been several small studies that have found the drug to be protective, but a larger clinical trial is needed to gain FDA approval.
In the trial details on ClinicalTrials.gov, researchers looked for people with allergies to peanuts, as well as two other foods that can cause bad reactions, such as tree nuts (cashews, hazelnuts or walnuts), milk and Eggs. According to the National Institutes of Health, participants ages 1 to 17 were enrolled, as well as three adults ages 18 to 55, all of whom consumed peanuts and at least two other common dietary supplements. Food allergy was confirmed.
At the beginning of the study, participants were given:
- 600 mg of peanut protein, which is equivalent to about two and a half peanuts.
- 1,000 mg 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 on a diet that contained proteins from several foods that cause allergic reactions.
Potential approval of Xolair for food allergies has been a long time coming, said Dr. Joyce Yu, an expert in pediatric allergy and immunology at Columbia University’s Vagelos College of Physicians and Surgeons.
Yu said FDA approval would likely make life easier for both doctors and patients, who said they have not used the drug off-label because it is 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.
The drug, which is a man-made antibody, works by reducing a component of the immune system called IgE, which is then released in abundance, said Dr. Cosby Stone, assistant professor of allergy and immunology at Vanderbilt University Medical Center. The body mistakenly identifies the allergen as a parasitic infection.
A drug that could make children with allergies less sensitive to common foods would be incredibly valuable to children, especially young children, and their parents because children should be protected from any type of exposure, Stone said. It is not easy to keep.
There is already evidence in group studies that shows it protects people from serious reactions, Stone said. But I think everyone in our field will 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 has granted priority review for Xolair.
Preliminary analysis showed that Xolair significantly increased the amount of primary target peanuts and milk, eggs and cashews that could cause allergic reactions in children and teens with food allergies, said Dr. Larry Tsai, director of respiratory, allergy and The global head of infectious disease product development at Genentech said in an email.
Full trial findings are expected to be published in a medical journal in late January or February.
Togias said FDA approval could come in the first quarter of 2024.
For Tsai, the test findings are personal, as she has food allergies and also has a child who suffers from severe food allergies.
“I know firsthand how challenging it is to deal with this situation and live in constant fear of sudden exposure,” Tsai said.
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