The U.S. Food and Drug Administration has approved the asthma drug Xolair (omalizumab) injection for immunoglobulin E-mediated food allergy in certain adults and children 1 year or older for the reduction of allergic reactions (Type I), including reducing the risk of anaphylaxis, that may occur with accidental exposure to one or more foods. Patients who take Xolair, manufactured by Genentech, must continue to avoid foods they are allergic to. Xolair is intended for repeated use to reduce the risk of allergic reactions and is not approved for the immediate emergency treatment of allergic reactions, including anaphylaxis.
Xolair was originally approved in 2003 for the treatment of moderate to severe persistent allergic asthma in certain patients. Xolair is also approved to treat chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps in certain patients.
According to the Centers for Disease Control and Prevention (CDC), almost 6% of people in the United States in 2021 had a food allergy and exposure to the particular food(s) to which they are allergic and can lead to potentially life-threatening allergic reactions (i.e., anaphylaxis). There is no cure for food allergy. However, according to Kelly Stone, MD, PhD, associate director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research, “Although [Xolair] 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. Xolair is the first FDA-approved medication to reduce allergic reactions to more than one type of food after accidental exposure.”
Xolair is a drug (in the class of drugs called monoclonal antibodies) that binds to immunoglobulin E (IgE), the antibody type that triggers allergic reactions, and blocks IgE from binding to its receptors.
Xolair’s safety and efficacy in reducing allergic reactions in subjects with food allergies was established in one multicenter, double-blind, placebo-controlled study of 168 pediatric and adult subjects (at least 1 year of age or older) who were allergic to peanut and at least two other foods, including milk, egg, wheat, cashew, hazelnut or walnut. The primary measure of Xolair’s efficacy was the percentage of subjects who were able to eat a single dose (600 milligrams or greater) of peanut protein (equivalent to 2.5 peanuts) without moderate to severe allergic symptoms, such as moderate to severe skin, respiratory or gastrointestinal symptoms, at the end of the 16- to 20-week treatment course. Of those who received Xolair, 68% (75 of 110 subjects) were able to eat the single dose of peanut protein without moderate to severe allergic symptoms (e.g., whole body hives, persistent coughing, vomiting), compared to 6% (3 of 55 subjects) who received placebo.
Xolair does come with a boxed warning for anaphylaxis, which can be life threatening, based on pre-marketing and post-marketing reports of anaphylaxis that occurred after Xolair administration. Anaphylaxis has occurred after the first dose of Xolair, but also has occurred beyond one year after beginning treatment. Xolair should only be started in a health care setting equipped to manage anaphylaxis. For selected patients who tolerate initial Xolair treatments in a health care setting without anaphylaxis, self-administration (or administration by a caregiver) may be appropriate and should be discussed with a health care provider.
