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FDA approves the first treatment to reduce the severity of food allergy reactions

Published June 12th, 2024

For the first time, the FDA has approved a treatment to reduce the severity of dangerous allergic reactions due to accidental exposure to food allergens. Here’s what to know about this new tool to help manage food allergies.

Xolair® reduces the severity of food allergies
The FDA has approved Xolair® (omalizumab) for immunoglobulin E (IgE)-mediated food allergies in adults and children aged 1 year or older for the reduction of allergic reactions that may occur with accidental exposure to one or more foods, including nuts, wheat, milk, dairy and other common allergens.1 Xolair® should not be used for immediate emergency treatment of allergic reactions, including anaphylaxis. It is designed as a maintenance therapy with the goal of lowering the risk of allergic reaction in case of accidental exposure, reducing the severity of the reaction, and decreasing the likelihood that it will be life-threatening.

Xolair® is a monoclonal antibody that works by blocking the antibody that triggers allergic reactions (IgE). Xolair® was originally approved in 2003 for the treatment of allergic asthma. A recent study published in the New England Journal of Medicine showed that treatment with Xolair® enabled people to be exposed to higher doses of allergenic foods before developing an allergic reaction. It also showed that people had less severe reactions when exposed to allergenic food.2

In the study, children with allergies to peanuts, tree nuts, eggs, milk, or wheat were treated with Xolair® by injection every 2–4 weeks. After 4 months of injections, they were challenged with exposure to a higher doses of food allergens than they would get from taking an accidental bite of that food. Around 67% of the children who were treated with Xolair® could tolerate these high doses without a severe reaction, versus just 7% of those treated with a placebo. Importantly, responses to Xolair® varied widely and 14% of children were unable to tolerate even a small amount of allergen after the treatment course.2 The most common side effects were reactions at the injection site, but these were still quite rare, occurring in fewer than 3% of patients.3

Administration of Xolair® for food allergies
Xolair® is administered by injection. It may cause severe immune responses, including anaphylaxis, so the first few doses are given in the doctor’s office to monitor the person who is getting the shot for any severe reactions. After ensuring that the person can get the shot without a dangerous reaction, doses can be given at home.1

To be effective, a person must continue to take Xolair® every two weeks, which has a monthly cost of about $2,900 for children and $5,000 for adults. It is currently unclear whether health insurance will cover Xolair® treatment for food allergies, but it is covered for asthma, and the manufacturer (Genentech) has a patient assistance program to help reduce the costs.

This therapy can help to reduce the anxiety that comes with having a food allergy or having a child with a severe food allergy. It also gives parents greater peace of mind that if their child accidentally consumes a food allergen, their reaction will remain mild and not life-threatening. Some people who took Xolair® did not have a reduction in the severity of their allergic reactions, so it is important to consult with a healthcare provider to determine whether Xolair® treatment is appropriate.


  1. Commissioner, O. of the. FDA Approves First Medication to Help Reduce Allergic Reactions to Multiple Foods After Accidental Exposure. FDA (2024).
  2. Wood, R. A. et al. Omalizumab for the Treatment of Multiple Food Allergies. New England Journal of Medicine 390, 889–899 (2024).
  3. XOLAIR- omalizumab injection, solution, Package Insert. Genentech, Inc. (2024).

About the Authors

Tracy Arsenault, MS, PA-C

Managing Clinical Director, ClearCare

Tracy is a board-certified Physician Assistant with experience as a Physician Assistant in Cardiology, Cardiothoracic and Vascular surgery. In addition, she has extensive experience as an exercise physiologist and clinical research associate with focus in muscle and aging, endocrinology, and nuclear medicine.

Sheley Baylon, PharmD

Senior Director, Research & Head of Pharmacology

Sheley is a licensed doctor of pharmacy with twelve years experience in pharmacy and laboratory research. She deciphers and analyzes medical literature to craft patient-friendly reports, empowering clients with the latest information for informed health decisions.