Roche's Xolair Emerges as Leader in Food Allergy Treatment

Roche's asthma drug Xolair has demonstrated superior efficacy and safety compared to oral immunotherapy in treating adults and children with multiple food allergies, according to new data from the Phase III OUtMATCH trial. The results, presented at the 2025 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting, further solidify Xolair's position as the leading treatment option for food allergies.

OUtMATCH Trial Results

The OUtMATCH trial revealed that 36% of patients treated with Xolair could tolerate at least 2,000 mg of peanut protein—equivalent to about eight peanuts—and two other food allergens without developing allergic reactions. In contrast, only 19% of patients undergoing oral immunotherapy (OIT) achieved the same outcome. This difference was statistically significant, with a p-value of 0.031.

Xolair's advantage was primarily attributed to the high rates of adverse events in the OIT group. Over 30% of OIT participants experienced serious adverse events, with 22.2% discontinuing treatment due to toxicities. Notably, none of the Xolair-treated patients developed severe side effects or had to drop out of the study.

Expanding Treatment Options

Following the trial, many Xolair-treated participants were able to introduce previously allergenic foods into their diets, although success varied by food type. Milk, egg, and wheat appeared more tolerable compared to peanuts and tree nuts. However, the study noted that many patients still had to avoid certain allergenic foods due to adverse events and other factors, including anaphylaxis and the need for epinephrine treatment.

Xolair's Mechanism and Regulatory Status

Xolair, a humanized monoclonal antibody, works by disrupting the interaction between IgE and its corresponding receptor, thereby interrupting the allergic cascade. Administered via subcutaneous injection, the drug has been approved for various indications since its initial authorization for moderate-to-severe asthma in 2003.

In a significant development, the FDA approved Xolair in February 2024 for mitigating allergic reactions following accidental exposure in adults and children with IgE-mediated food allergies. This approval made Xolair the first and only FDA-approved treatment for individuals with one or more food allergies, although it is not classified as an emergency treatment for anaphylaxis.