In a significant development for the treatment of food allergies, the U.S. Food and Drug Administration (FDA) has granted approval for Xolair (omalizumab) injection. Xolair is now approved for use in certain adults and children over the age of one to reduce allergic reactions, including the risk of anaphylaxis, that may occur with accidental exposure to various types of food.

While Xolair does not eliminate food allergies or enable patients to freely consume allergens, it aims to minimize the health impact of accidental exposure. Patients taking Xolair must continue to avoid the foods they are allergic to. Xolair is intended for repeated use to reduce the risk of allergic reactions and is not to be administered for immediate emergency treatment of allergic reactions, including anaphylaxis.

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, stated, "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."

According to the Centers for Disease Control and Prevention, approximately 6% of people in the United States suffer from food allergies in 2021, and exposure to allergenic foods can lead to potentially life-threatening allergic reactions, including anaphylaxis. Presently, the only available treatment involves strict avoidance of allergenic foods and the immediate administration of epinephrine in case of accidental exposure.

Xolair previously received FDA approval in 2003 for the treatment of moderate to severe persistent allergic asthma in specific patients. It has since been approved to treat chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps in certain patients.

Xolair is a monoclonal antibody drug that binds to immunoglobulin E (IgE), the type of antibody responsible for triggering allergic reactions. By blocking the binding of IgE to its receptors, Xolair aims to reduce allergic reactions.

The FDA's approval of Xolair for reducing allergic reactions in individuals with food allergies was based on a double-blind, placebo-controlled study that included 168 pediatric and adult subjects who were allergic to peanut and at least two other foods. The study showed that 68% of subjects treated with Xolair could consume a single dose of peanut protein without experiencing moderate to severe allergic symptoms, compared to only 6% of subjects who received a placebo.

The study also assessed the efficacy of Xolair in reducing allergic reactions to cashew, milk, and egg proteins. The results showed that a significant percentage of subjects treated with Xolair achieved the targeted reduction in allergic symptoms compared to those who received a placebo.

The most common side effects observed with Xolair were injection site reactions and fever. The drug comes with specific warnings and precautions, including the risk of anaphylaxis, malignancy, fever, joint pain, rash, parasitic infections, and abnormal laboratory tests. As a precaution, Xolair should only be initiated in a healthcare setting equipped to manage anaphylaxis.

Genentech is the company responsible for the development of Xolair and has been granted the approval by the FDA for its use in reducing allergic reactions in food allergy patients.

This approval marks a significant step forward in offering a treatment option to individuals with IgE-mediated food allergies. While it does not provide a cure, Xolair's ability to reduce the risk of allergic reactions after accidental exposure to various foods brings hope to those affected by food allergies.