Xolair (omalizumab), an asthma drug sold by Roche and Novartis, has significantly lowered allergic reactions in individuals with multiple severe food allergies in the National Institutes of Health (NIH)-sponsored Phase 3 OUtMATCH trial.

Xolair is a monoclonal antibody that was first approved by the US Food and Drug Administration (FDA) in 2003 to treat asthma.

Based on the findings from this late-stage trial, the US FDA recently approved the expanded use of Xolair in children and adults with immunoglobulin E (IgE)-mediated food allergies.

The first stage of the study was designed to assess if omalizumab increased the threshold for food that caused allergic reactions, thereby reducing the chances of reactions to small amounts of food allergens during accidental exposure.

The three-stage, multicentre, randomised, double-blind, placebo-controlled study enrolled 177 children and adolescents aged one to 17 years and three adults aged 18 to 55 years, all with confirmed and severe food allergies.

In the trial, a 16-week course of omalizumab enhanced the quantity of peanut, tree nut, egg, milk, and wheat that multi-food allergic infants as young as one year old could eat without experiencing an allergic reaction.

Compared to less than 7% of participants who got a placebo, over 67% of people who finished the antibody therapy were able to take a single dose of 600 mg or more of peanut protein without experiencing a mild to severe allergic reaction.

The researchers concluded that Xolair could protect kids and teenagers from harm if they inadvertently consume an allergic meal.

OUtMATCH study principal investigator Robert Wood said: “While allergic reactions to exposures are common and often severe, there have been limited treatment advancements for food allergy.

“The results of the OUtMATCH study showed that anti-IgE therapy could significantly reduce the occurrence of allergic reactions across multiple foods in the event of an accidental exposure.”

After completing the first stage, the first 60 patients received further oral meal challenges and a 24-week open-label extension of omalizumab injections.

The trial was funded by the National Institute of Allergy and Infectious Diseases (NIAID) with additional support from and collaboration with Genentech, a member of the Roche Group, and Novartis.