Trial data underpins FDA approval of omalizumab for food allergy

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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