The Food and Drug Administration approved omalizumab to reduce allergic reactions and anaphylaxis in people with food allergies. The approval was based on data from a Phase 3 clinical trial sponsored by the National Institute of Allergy and Infectious Diseases. The trial called Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Children and Adults (OUtMATCH). Final results of the trial will be presented at a later date. Omalizumab previously received FDA approval for three other indications, including the treatment of moderate-to-severe persistent allergic asthma. The approval highlights the importance of NIH-supported research underlying the FDA decision.
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Trial data underpins FDA approval of omalizumab for food allergy
