The National Institute of Allergy and and Infectious Diseases (NIAID) is working on a study to lessen the symptoms of children with multiple food allergies.
The trial is utilizing omalizumab, or Xolair, a lab-made antibody that is currently approved by the U.S. Food and Drug Administration (FDA) for treating childhood asthma and hives. At this stage of the clinical trial, researchers found that when children took Xolair, they could consume higher quantities of food they were allergic to before initiating a reaction.
“Despite the significant and growing health burden from food allergies, treatment advances have been limited,” said Dr. Levi Garraway, chief medical officer and head of Global Product Development at Genentech, the company producing Xolair.
“The FDA’s priority review designation acknowledges the unmet need for these patients, and we hope to make Xolair available to as many people as possible living with food allergies in the U.S.”
A look at the study
To test the effectiveness of Xolair for children with multiple food allergies, the researchers enrolled children and adolescents with allergies to peanuts and at least one other food like milk, eggs, or tree nuts.
Researchers gave one group the Xolair injection and one group a placebo injection. Then, participants were given small, varying doses of peanut protein, milk protein, egg protein, and proteins from other foods that cause allergic reactions.
Overall, 165 children who were given Xolair had milder allergy symptoms compared to children who received the placebo.
According to the trial results, Xolair was effective at prolonging the start of children’s allergic reaction symptoms. Participants who were given the drug were able to consume more of the foods they were allergic to before showing signs of a reaction.
What happens next?
The goal now is for Xolair to receive FDA approval for treating children with multiple food allergies, which would expand consumers’ access to the drug for allergy purposes. Currently, Xolair is under Priority Review from the FDA, and the full clinical trial is expected to run through 2026.
“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,” Dr. Alkis Togias, chief of the allergy, asthma, and airway biology branch at NIAID, told NBC News.
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Posted: 2024-01-03 12:24:47
