Xolair: Two Years In

Severe food allergies can make navigating school, social situations, and other aspects of daily life difficult, as even a minuscule amount of an allergen can potentially cause a life-threatening reaction. Xolair’s (omalizumab) use in the food allergy community aimed to help by providing a safety net for small amounts of common allergens. “Xolair for subcutaneous use is an injectable prescription medicine used to treat food allergy in people 1 year of age and older to reduce allergic reactions that may occur after accidentally eating one or more foods to which you are allergic.”

The idea behind Xolair is to raise the allergen threshold, so that more of an allergen could be inadvertently ingested without producing a reaction. This reduces the danger of common risk factors like cross-contamination, unintended exposure, and more. On February 16, 2024, the FDA approved Xolair for use in adults and children aged one year and older.

Prior to its FDA approval, a research study entitled “Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Children and Adults”, or OUtMATCH, was published in the New England Journal of Medicine. It is a Phase III clinical research trial funded by the National Institute of Allergy and Infectious Diseases (NIAID), a branch of the NIH. The study demonstrated that Xolair was successful in preventing allergic reactions in allergy patients. 

Across all seven allergens tested, the Xolair group consistently outperformed the placebo group by a wide margin. At a 600 mg dose, 67% of peanut-allergy patients in the Xolair group tolerated the test dose, compared to just 7% in the placebo group. At 1,000 mg doses, success rates for the Xolair group ranged from 41% to 75% across egg, milk, hazelnut, walnut, wheat, and cashew (with wheat yielding the highest success rate at 75% and cashew the lowest at 41%). The placebo group, by contrast, never exceeded 14% across any allergen.

The data shows an overwhelming success rate among people who took Xolair, which wasn’t present for people who took the placebo. 

Even though the drug has already been approved for use by the FDA, researchers continue to study its efficacy. In February 2026, new data from Stage III of OUtMATCH indicates that Xolair is just as effective as OIT in terms of achieving allergen desensitization for certain foods. In fact, according to the American Academy of Allergy, Asthma, and Immunology (AAAAI), “There is no significant difference between the successful consumption of allergenic foods when using omalizumab versus multi-food oral immunotherapy.”

“The OUtMATCH Stage III results are encouraging for  families living with multiple food allergies. After approximately one year of treatment with either omalizumab facilitated multi-food oral immunotherapy or omalizumab alone, more than 60% of participants were successfully eating their allergenic foods regularly. Both treatment approaches appear to open a pathway to dietary inclusion with comparable safety and success.”

A specific example of Xolair’s potential superiority to OIT was during a Stage II testing round, where patients were exposed to their respective allergen in an OIT group and a Xolair group. From The Journal of Allergy and Clinical Immunology (JACI), “In the intent-to-treat analysis of the primary endpoint, omalizumab [(Xolair)] was superior to OIT [in not eliciting a reaction] according to JACI.

Two years after its initial approval Xolair continues to demonstrate that it is an effective and multifunctional treatment for managing long-term allergy symptoms.