FDA approves Xolair to treat allergic reactions to multiple foods

Xolair, an asthma medication, can be given to children – intended for repeated use – to help reduce allergic reactions.

The U.S. Food and Drug Administration (FDA) has approved Xolair (omalizumab) injection as the first medication to help reduce allergic reactions to multiple foods after accidental exposure.

Xolair is approved for use in certain adults and children (1 year or older) with immunoglobulin E-mediated food allergy to reduce the risk of allergic reactions (Type I) and the potential for anaphylaxis following accidental exposure to one or more foods.


Driving the news: Xolair, originally approved in 2003 for the treatment of moderate to severe persistent allergic asthma, is now also approved for the treatment of chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps.

  • The FDA’s approval of Xolair as a treatment for food allergies will provide an additional option for reducing the risk of harmful allergic reactions in certain patients with IgE-mediated food allergies.
  • According to the Centers for Disease Control and Prevention, approximately 6% of people in the United States in 2021 had a food allergy, and exposure to allergenic foods can lead to potentially life-threatening allergic reactions.

How it works: Xolair works by binding to immunoglobulin E (IgE), the antibody that triggers allergic reactions, and blocks its interaction with receptors.

  • The safety and efficacy of Xolair in reducing allergic reactions to food allergies were established in a study involving pediatric and adult subjects allergic to peanuts and at least two other foods.
  • The study found that 68% of the subjects who received Xolair were able to eat a single dose of peanut protein without experiencing moderate to severe allergic symptoms, compared to only 6% of those who received a placebo.
  • The most common side effects observed with Xolair were injection site reactions and fever.
  • Xolair comes with warnings and precautions, including the risk of anaphylaxis, malignancy, fever, joint pain, rash, parasitic infection, and abnormal laboratory tests.

What they’re saying: “This newly approved use for Xolair will provide a treatment option to reduce the risk of harmful allergic reactions among certain patients with IgE-mediated food allergies,” said Kelly Stone, M.D., Ph.D., associate director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research. “While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs.” 

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