Home Medizin Die FDA genehmigt Omalizumab für Nahrungsmittelallergien auf Grundlage einer NIH-Forschung

Die FDA genehmigt Omalizumab für Nahrungsmittelallergien auf Grundlage einer NIH-Forschung

von NFI Redaktion

Food Allergy

The recent approval of an additional biologics license for the monoclonal antibody Omalizumab (Xolair) by the Food and Drug Administration underscores the critical role of research supported by the National Institutes of Health that underpins the FDA’s decision-making.

The FDA has approved Omalizumab for reducing allergic reactions, including anaphylaxis, that can occur in adults and children as young as 1 year old with food allergies due to accidental contact with one or more food items. People taking Omalizumab must continue to avoid contact with the foods to which they are allergic. Omalizumab had previously received FDA approval for three other indications, including the treatment of moderate to severe persistent allergic asthma in certain patients.

The new FDA approval is based on data from a planned interim analysis of a clinical phase 3 study sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), a part of the NIH. The study, named Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Children and Adults, abbreviated as OUtMATCH, was conducted by researchers from the NIH-funded Consortium for Food Allergy Research.

Detailed final results from the first phase of the study will be presented at the annual meeting of the American Academy of Allergy, Asthma & Immunology in Washington, D.C. as part of a current symposium titled „Omalizumab for the Treatment of Food Allergies: The OUtMATCH Study“ on Sunday, February 25, 2024, at 1:45 p.m. ET. A summary of the final results was published in an online supplement of the Journal of Allergy and Clinical Immunology on February 5, 2024.

NIAID is funding the study with additional support and collaboration from Genentech, a member of the Roche group, and Novartis Pharmaceuticals Corporation. Both companies are involved in the development and marketing of Omalizumab and provide it for the study.

More information about the ongoing OUtMATCH study can be found on ClinicalTrials.gov under the study identifier NCT03881696.


NIH/National Institute of Allergy and Infectious Diseases

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