New Drug May Prevent Severe Food Allergy Reactions in Children

Early data analysis from a clinical trial suggests that an injectable drug already approved to treat asthma and chronic hives can also prevent allergic reactions to peanuts, eggs, milk, and cashews in children and teens.

Around 2% of adults and 4% to 8% of children in the United States have food allergies. Moreover, food-related anaphylaxis — a severe and potentially life-threatening allergic reaction — leads to 30,000 emergency room visits, 2,000 hospitalizations, and 150 deaths in the U.S. each year.

Currently, there are no preventative treatments for food allergies. So, a person must strictly avoid exposure to food allergens to reduce the risk of a reaction. This can pose a challenge since allergens can be difficult to detect in foods that contain several ingredients.

However, a new medicine to prevent food allergy reactions may be available soon.

Preliminary results of the multi-stage clinical trial — Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Children and Adults (OUtMATCH) — show that the laboratory-made antibody, omalizumab reduced the likelihood of allergic reactions to foods in young participants.

The trial, funded by the National Institute of Allergy and Infectious Diseases (NIAID), recruited children and teens ages one to 17 and three adults ages 18 to 55. All participants had confirmed allergies to peanuts and at least two other foods.

During the first stage of the trial, participants who received omalizumab injections could consume higher amounts of peanuts, eggs, milk, and cashews without experiencing an allergic reaction. Trial participants given placebo injections did not experience this protective effect.

According to a National Institutes of Health (NIH) news release, more detailed information about the findings will become available when the clinical trial results are published in a peer-reviewed journal.

What is omalizumab — the potential new food allergy drug?

Omalizumab, a biologic medication known as Xolair, was FDA-approved in 2003 to treat persistent asthma and chronic hives in children and adolescents ages 12 and older. It is a recombinant DNA-derived humanized IgG1κ monoclonal antibody that selectively binds to human immunoglobulin E (IgE).

While shown to be effective in treating asthma and hives, the medication may cause serious side effects, including cancer, blood vessel inflammation, and heart problems.

Moreover, the drug's price tag is high. NBC reports that the monthly cost of Xolair for asthma is about $3,663, and people typically take it for around ten months.

Genentech, the maker of omalizumab, recently announced that the FDA granted priority review of the drug based on the clinical trial's promising results, placing it one step closer to approval for food allergy treatment.

In a press release, Levi Garraway, M.D., Ph.D., Genentech's chief medical officer and head of Global Product Development, said, "Despite the significant and growing health burden from food allergies, treatment advances have been limited. 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."

Genentech works with Novartis Pharmaceuticals Corporation in the development and co-promotion of Xolair.

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