On February 16, 2024, the Food and Drug Administration approved Xolair as the “First Medication to Help Reduce Allergic Reactions to Multiple Foods After Accidental Exposure”

What is Xolair?

Xolair (omalizumab) is a monoclonal antibody that binds to IgE (the allergic antibody our bodies make). You can think of it like the arcade game with the crane that grabs stuffed animals only it does it much better. By doing so, fewer of the allergic antibodies end up on allergy cells. This appears to tamp down allergic reactions.

What did the OutMATCH Study find?

In a group of very allergic children (average age of 7) who were allergic to peanut and at least 2 other foods (milk, egg, cashew, walnut, hazelnut and/or wheat), a total of 79 out of 118 (67%) were able to eat at least 1 gram of peanut protein (equal to 4 peanuts) without reaction after 16-20 weeks of shots given every 2-4 weeks (interval based on weight and total IgE level).

For other foods, 80% of the participants were able to eat a total of 1 gram of any one of their allergic food without reaction; 69% could eat 1 gram of two foods and 47% could eat 1,000mg of three of their allergenic foods (for those with cashew allergy, results were not quite as good).

What does this mean for you/your child?

Xolair would need to be given as one or more injections under the skin (subcutaneous) either every 2 weeks or every 4 weeks based on weight and a blood test to check IgE levels. Protection from accidental ingestion would not be expected until 16 weeks of injections. Some people will have IgE levels that are too high for Xolair to be effective. For one Massachusetts site in the OutMATCH Study, almost 25% of those that expressed interest were excluded as their IgE levels were too high.

Can I/my child stop checking labels or start eating foods they are allergic to?

NO. The study did not show that children could eat the foods they were allergic to. Xolair essentially offers a ‘safety net’ in case of accidental ingestion of up to 1 gram of food being eaten for approximately 2 out of 3 children who use this medication regularly.

How much does Xolair cost?

The estimated cost of a single injection of Xolair is $1,300. Xolair is NOT currently covered by insurance companies for this indication. It may take weeks to months for insurance companies to decide on the criteria that would allow coverage.