Children’s Healthcare of Atlanta and Emory University participated in a nationwide clinical trial showing that a 16-week course of omalizumab, an injectable drug, increased the amount of peanut, tree nuts, egg, milk and wheat that some multi-food allergic children as young as one year could consume without an allergic reaction after exposure. Findings were published yesterday in the New England Journal of Medicine, following U.S. Food and Drug Administration (FDA) approval earlier this month based on interim data from the trial.
The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, sponsors and funds the trial.
“An estimated 8% of children in the U.S. suffer from food allergies, and almost half of those children have multiple food allergies,” said Brian Vickery, MD, Principal Investigator of the Children’s and Emory study site, Chief of Allergy and Immunology at Children’s and Marcus Professor of Pediatric Immunology at Emory. “Until now, those allergic to multiple foods have had no approved solutions. While not a cure, omalizumab is the first medicine available that could help reduce allergic reactions to multiple foods following an accidental exposure, which will provide a great benefit to many of these patients.”
The FDA approved omalizumab, also known by the brand name Xolair, for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy. Patients who take omalizumab must continue to avoid foods they are allergic to, and the drug is intended for repeated use to reduce the risk of allergic reactions and is not approved for the immediate emergency treatment of allergic reactions, including anaphylaxis, the FDA states. Genentech, a member of the Roche Group, and Novartis Pharmaceuticals Corporation work together to develop and co-promote…
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