Use of Asthma drug Omalizumab for Severe Food Allergies

Individuals with severe food allergies, such as those to milk, peanuts, and shellfish, now have a new option to protect themselves from dangerous reactions in case of accidental exposure to these foods. The US Food and Drug Administration (FDA) announced on February 16th that a drug called Xolair (generic name omalizumab) has received approval for treating multiple severe food allergies.

Xolair is an injectable drug classified as a monoclonal antibody, which means it contains lab-made proteins that target specific sites within the body. Once injected, Xolair latches onto immunoglobulin E (IgE), the type of antibody that’s mainly responsible for most allergic reactions.

Various food allergies are caused by IgE, including those to milk, eggs, soy, peanuts, tree nuts, fish, shellfish, and wheat (wheat allergy caused by IgE is distinct from celiac disease, an autoimmune condition caused by different immune system elements).

Although Xolair has been previously approved for treating allergic asthma and other conditions, its latest approval means it can now be used to prevent allergic reactions arising from multiple food triggers.

“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,” Dr. Kelly Stone, associate director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research, said in Friday’s statement.

“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,” Stone said.

Xolair is a drug that helps people build tolerance to allergens and reduce the severity of their allergic reactions if they are exposed. It is not a replacement for epinephrine injections, such as EpiPen devices, which are used to reverse a life-threatening allergic reaction called anaphylaxis. The EpiPen injection keeps a person’s airways open and blood pressure stabilized in case they have exposure to an allergen and have this dangerous reaction.

The recommended dosage and timing of Xolair injections vary depending on a person’s body weight and the amount of IgE in their blood. The injections can be given by a healthcare provider or at home through self-injection.

In a trial that included nearly 170 adolescents and children at least 1 year old, as well as three adults, Xolair was tested. All participants were allergic to peanuts and at least two additional foods confirmed by various tests, including a skin-prick test and IgE test. The participants received either Xolair or a placebo for four to five months.

The researchers found that 68% of those who received Xolair were able to consume a dose of peanut protein without moderate to severe symptoms, such as whole-body hives or vomiting. That’s compared with only 6% of the placebo group. The researchers also saw similar rates of improvement when it came to people’s reactions to cashews, milk and eggs. The observed levels of protection “are likely to exceed those that would be needed for the amounts of food that are typically encountered during accidental exposure.”

However, 17% of people who took Xolair saw no change in their peanut tolerance over time. As a result, continuation of strict allergen avoidance is still necessary, despite treatment with Xolair. Additional studies will be needed to fully understand the reasons for treatment failures, as well as whether the therapy could actually help treat the core cause of people’s allergies if used regularly and shortly after diagnosis.

The most common side effects of the injection were fever and reactions at the injection site. The drug’s label also warns of potential fevers, joint pain, rashes, and parasitic worm infections. Blocking the antibodies might raise the risk of such infections as IgE is thought to be key to fighting off parasites.

The FDA emphasized that people should initially receive Xolair in a health care setting, as there have been some reported cases of patients experiencing anaphylaxis shortly after the drug’s administration.

This news is a creative derivative product from articles published in famous peer-reviewed journals and Govt reports:

1. Mortz, C. G., Parke, L., Rasmussen, H. M., Kjaer, H. F., & Bindslev‐Jensen, C. (2024). A randomized, double‐blind placebo‐controlled study on the efficacy of Omalizumab on food allergy threshold in children with severe food allergy. Allergy.
2. Ezhuthachan, I. D., Beaudoin, M., Nowak-Wegrzyn, A., & Vickery, B. P. (2024). The Future of Food Allergy Management: Advancements in Therapies. Current Allergy and Asthma Reports, 1-11.
3. Chase, N. M., Littlejohn, M., Holweg, C. T., Millette, L. A., Seetasith, A., Steinke, J. W., … & Casale, T. B. (2024). Effectiveness of omalizumab across different dosing regimens in patients with moderate-to-severe allergic asthma. Respiratory Medicine, 223, 107537.
4. Barshow, S., Tirumalasetty, J., Sampath, V., Zhou, X., Seastedt, H., Schuetz, J., & Nadeau, K. (2024). The Immunobiology and Treatment of Food Allergy. Annual Review of Immunology, 42.
5. Honda, A., Okada, Y., Matsushita, T., Hasegawa, T., Ota, E., Noma, H., … & Kwong, J. (2024). Efficacy of biological agents combined with oral immunotherapy (OIT) for food allergy: a protocol for a systematic review and meta-analysis. BMJ open, 14(2), e075253.

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