What is Xolair?
Xolair is an anti-IgE monoclonal antibody by Genentech and Novartis that works by inhibiting the allergic reaction process. On February 16, 2024, it was approved by the FDA for the reduction of food allergic reactions, including anaphylaxis, in people with food allergies.
Is Xolair Approved for Food Allergies?
Yes. In February 2024, the FDA approved Xolair as the first and only medicine to reduce allergic reactions for people with one or more food allergy. It may not be appropriate for all patients with food allergy. Clinical criteria for the appropriate patients are still in development, but Xolair is available now for patients with severe food allergies.
How Does Xolair Work?
Xolair is an anti-IgE monoclonal antibody that works by inhibiting the allergic reaction process. At Allergy and Asthma Care of Fairfield County, we will be offering Xolair for appropriate food allergy patients, and may in the future be using it in conjunction with oral immunotherapy.
For more background on oral immunotherapy with anti-IgE Xolair (omalizumab), we recommend the following published studies and meta-analysis:
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Omalizumab for the Treatment of Multiple Food Allergy (OUtMATCH)
- A Phase 2 Randomized Controlled Multisite Study Using Omalizumab-facilitated Rapid Desensitization to Test Continued vs Discontinued Dosing in Multifood Allergic Individuals, Lancet 2019
- Anti-IgE treatment with oral immunotherapy in multifood allergic participants: a double-blind, randomised, controlled trial, Lancet Gastroenterology and Hepatology, 2018
- Observational long-term follow-up study of rapid food oral immunotherapy with omalizumab, Allergy, Asthma & Clinical Immunology 2017
- Combining anti-IgE with oral immunotherapy, Pediatric Allergy & Immunology 2017
- Omalizumab facilitates rapid oral desensitization for peanut allergy, Journal of Allergy and Clinical Immunology 2017
- A randomized, double-blind, placebo-controlled study of omalizumab combined with oral immunotherapy for the treatment of cow’s milk allergy, Journal of Allergy and Clinical Immunology 2017
Is Xolair Covered by Insurance?
With the recent FDA approval of Xolair, it is likely to be covered by insurance. Previously, Xolair had been granted Breakthrough Therapy Designation for the prevention of severe allergic reactions to food allergy by the FDA, but this was considered an off-label usage and often not covered by insurance. If our allergist prescribes this medication for you, we can work with you and your insurance plan to help understand if there will be any out-of-pocket costs before proceeding.
From the AAAAI:
Study highlights a valuable option for safe and effective food allergy treatment.
Washington, DC – Sixteen weeks of omalizumab results in a higher tolerated threshold for multiple food allergies according to new research presented today at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting and published in the New England Journal of Medicine.
“Food allergies affect millions of individuals in the U.S., and those impacted face a daily threat of life-threatening reactions. This can lead to substantial anxiety with a profound effect on quality of life. To remain safe, constant vigilance is required and even then, accidental exposures are very common,” said Dr. Robert A. Wood, MD, FAAAAI, lead author of the study. “The OUtMATCH study demonstrated that omalizumab (Xolair) significantly increased the threshold for reaction in most patients for peanut and the six other foods studied, enough to provide real protection against small, accidental exposures. We are extraordinarily excited by this advance in the world of food allergy.”
The results found that in multi-food allergic patients as young as a year old, 16 weeks of omalizumab treatment was superior to placebo in increasing the reaction threshold for peanut and other common food allergens to levels that would likely protect against reactions upon accidental exposure. As food allergies are common, this study highlights a valuable option for safe and effective food allergy treatment.
Researchers screened 1- to 55-year-old participants who were allergic to peanuts and two additional study-specified foods. Study inclusion required food challenge reactivity to be less than 100 mg of peanut protein and less than 300 mg of two other foods. Participants were then randomized to receive 16 weeks of omalizumab or a placebo, after which the food challenges were repeated to find the proportion of participants who could ingest 600 mg or more of peanut protein and 1000 mg or more of the other foods without dose-limiting symptoms. The first 60 participants entered a 24-week open-label extension.
Of the 462 screened participants, 180 were randomized and 120 were treated with omalizumab. Of the omalizumab-treated participants 66.7% achieved the primary endpoint compared to only 6.7% of the participants who received a placebo. Most participants maintained or increased their reaction threshold during the open-label extension, and the treatment success was associated with higher total IgE, smaller skin test size and higher tolerated baseline food challenge dose. Safety outcomes were similar between the groups. The study was funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH. Genentech, a member of the Roche Group, and Novartis Pharmaceuticals Corporation also supported the work.
Visit the AAAAI to learn more about food allergies. Research presented at the AAAAI Annual Meeting, February 23-26 in Washington, DC, is published in an online supplement to The Journal of Allergy and Clinical Immunology.
The American Academy of Allergy, Asthma & Immunology (AAAAI) is the leading membership organization of more than 7,100 allergists, asthma specialists, clinical immunologists, allied health professionals and other professionals with a special interest in the research and treatment of allergic and immunologic diseases. Established in 1943, the AAAAI has more than 7,100 members in the United States, Canada and 72 other countries and is the go-to resource for patients living with allergies, asthma and immune deficiency disorders.
