Xolair is the first and only FDA-approved medicine to reduce allergic reactions in people with one or more food allergies
On February 16, 2024, the U.S. Food and Drug Administration (FDA) approved Xolair (omalizumab) injection for immunoglobulin E–mediated food allergy in certain adults and children 1 year or older for the reduction of allergic reactions —including reducing the risk of anaphylaxis— that may occur with accidental exposure to one or more foods, including peanuts and cashews.
The safety and efficacy of omalizumab in reducing allergic reactions in subjects with food allergies was established in a clinical trial published in the New England Journal of Medicine earlier this year. This multi-center, double-blind, placebo-controlled study included 168 participants who were allergic to peanut and at least two other foods, including milk, egg, wheat, cashew, hazelnut or walnut. Participants were given either omalizumab or placebo treatment for 16 to 20 weeks.
The primary measure of omalizumab’s efficacy was the percentage of participants who were able to eat a single dose (≥600 mg) of peanut protein (equivalent to 2.5 peanuts) without moderate to severe allergic symptoms at the end of the course of treatment. Of those who received omalizumab, 68% were able to eat the single dose of peanut protein without moderate to severe allergic symptoms, compared to 6% who received the placebo. The key secondary measure of efficacy was the percentage of participants who were able to consume a single dose (≥1,000 mg) of cashew, milk or egg protein without moderate to severe allergic symptoms at the end of the course of treatment. For cashew, 42% of participants who received omalizumab achieved this endpoint compared to 3% of those who received the placebo.
The researchers concluded that omalizumab treatment for 16 weeks was superior to placebo in increasing the reaction threshold for peanut and other common food allergens, including cashew, in individuals as young as 1 year of age.
Wood, R. A., Togias, A., Sicherer, S. H., Shreffler, W. G., Kim, E. H., Jones, S. M., Leung, D. Y. M., Vickery, B. P., Bird, J. A., Spergel, J. M., Iqbal, A., Olsson, J., Ligueros-Saylan, M., Uddin, A., Calatroni, A., Huckabee, C. M., Rogers, N. H., Yovetich, N., Dantzer, J., Mudd, K., … Chinthrajah, R. S. (2024). Omalizumab for the Treatment of Multiple Food Allergies. The New England Journal of Medicine, 10.1056/NEJMoa2312382. Advance online publication.