April 12, 2024

Groundbreaking Trial Data Supports FDA Approval of Omalizumab for Food Allergy Treatment

The recent approval by the Food and Drug Administration (FDA) of a supplementary biologics license for the monoclonal antibody omalizumab (Xolair) is a significant milestone, underscoring the importance of research supported by the National Institutes of Health (NIH) in shaping regulatory decisions.

Omalizumab has now been greenlit by the FDA for the management of allergic reactions, including the severe condition of anaphylaxis, that may arise from accidental exposure to various food allergens in both adults and children as young as one year old. Nonetheless, individuals using omalizumab are advised to continue avoiding foods to which they are allergic. Prior to this recent approval, omalizumab had already secured FDA authorization for three other uses, notably for treating moderate-to-severe persistent allergic asthma in specific patient populations.

The FDA’s decision to approve omalizumab for food allergies was founded on data obtained from a planned interim analysis of a Phase 3 clinical trial supported by the National Institute of Allergy and Infectious Diseases (NIAID), a component of NIH. The trial, known as Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Children and Adults (OUtMATCH), was conducted by researchers within the Consortium for Food Allergy Research.

Comprehensive findings from the initial phase of the trial are set to be unveiled at the upcoming American Academy of Allergy, Asthma & Immunology Annual Meeting in Washington, D.C. A late-breaking symposium with the title “Omalizumab for the Treatment of Food Allergy: The OUtMATCH Study” is scheduled for Sunday, February 25, 2024, at 1:45 pm Eastern Time. An abstract outlining the final results has been published in an online supplement of the Journal of Allergy and Clinical Immunology on February 5, 2024.

1. Source: Coherent Market Insights, Public sources, Desk research
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