Xolair Effectively Reduces Multi-Food Allergic Reactions: Phase III Study in NEJM

Genentech, a prominent biotechnology firm and part of the Roche Group, has made significant strides in advancing treatment options for those suffering from food allergies. The company has recently announced the results of a pivotal Phase III study, OUtMATCH, which evaluated the efficacy and safety of Xolair® (omalizumab) in patients with allergies to peanuts and at least two other common foods. The study, sponsored by the National Institutes of Health (NIH), was published in the New England Journal of Medicine and presented at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.

The OUtMATCH study demonstrated that Xolair treatment increased the threshold at which moderate to severe allergic reactions occurred in patients as young as one year old. This advancement is particularly noteworthy as it provides a new therapeutic option for managing food allergies, which can significantly impact the quality of life for patients and their families. The U.S. Food and Drug Administration (FDA) has approved the expanded use of Xolair for individuals with IgE-mediated food allergies, based on the data from the OUtMATCH study.

Xolair is an antibody designed to target and block immunoglobulin E (IgE), thereby reducing the release of mediators in the allergic inflammatory cascade. This approval marks Xolair as the first and only FDA-approved medicine for reducing allergic reactions in people with one or more food allergies. It is crucial to note that Xolair is not intended for emergency treatment of allergic reactions, including anaphylaxis, and patients should continue to avoid foods they are allergic to.

The study included 180 patients aged 1 to 55 years old, who were unable to tolerate specific amounts of peanut and other food proteins. After treatment with Xolair or a placebo, participants underwent blinded food challenges to assess their ability to consume increased amounts of the proteins without severe reactions. The results showed a higher proportion of Xolair-treated patients could consume the predefined threshold doses of the proteins without experiencing severe allergic reactions.

Genentech's commitment to scientific excellence and improving patient lives is evident in their ongoing research and development efforts. The company's headquarters are located in South San Francisco, California, and they continue to be at the forefront of biotechnology innovation.