From NIH Labs to FDA Approval

Food and Drug Administration greenlights Omalizumab (Xolair) supplemental biologics license with NIH research backing, as published in the Journal of Allergy and Clinical Immunology (1^✔ ✔Trusted Source
Statement: NIH Trial Data Underpins FDA Approval of Omalizumab for Food Allergy

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The detailed final results from the first stage of the trial will be presented at the American Academy of Allergy, Asthma & Immunology Annual Meeting in Washington, D.C. during a late-breaking symposium titled, “Omalizumab for the Treatment of Food Allergy: The OUtMATCH Study” on Sunday, Feb. 25, 2024, at 1:45 pm ET.

FDA has approved omalizumab for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adults and children aged 1 year and older with food allergies. People taking omalizumab still need to avoid exposure to foods to which they are allergic. Omalizumab previously received FDA approval for three other indications, including treating moderate-to-severe persistent allergic asthma in certain patients.

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

Reference:

1. Statement: NIH Trial Data Underpins FDA Approval of Omalizumab for Food Allergy
   – (https://www.niaid.nih.gov/news-events/statement-nih-trial-data-underpins-fda-approval-omalizumab-food-allergy)

Source-Eurekalert