First Drug to Help Reduce Allergic Reactions to Multiple Food Allergies, Tested at Children’s and Emory, Now FDA Approved

ATLANTA (Monday, Feb. 26) – 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 one 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 Xolair.

The first stage of the trial known as OUtMATCH, “Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Children and Adults,” was administered at 10 sites nationwide through the NIAID-funded Consortium for Food Allergy Research. The study was designed to see if taking omalizumab increased the threshold amount of food that caused allergic reactions, reducing the likelihood of reactions to small amounts of food allergens during accidental exposure. The study team enrolled 177 children and adolescents ages 1 to 17 years and three adults ages 18 to 55 years with confirmed allergy to peanut and at least two other common foods among milk, egg, cashew, wheat, hazelnut or walnut. Participants who reacted during oral food challenges at baseline prior to treatment were assigned at random to receive injections of omalizumab or a placebo. After 16 to 20 weeks of treatment, the participants were challenged again in a carefully controlled setting to see if they could tolerate a greater amount of food than they did at the outset.

Results showed that nearly 67% of participants who completed treatment with omalizumab could consume about 2.5 peanuts (600mg) without a moderate or severe allergic reaction, in contrast with less than 7% of participants who received placebo. Treatment with omalizumab yielded similar outcomes for egg, milk, wheat, cashew, walnut and hazelnut at a dose of 1,000 mg of protein or more, suggesting the therapy has the potential to reduce allergic reactions in children if they accidentally eat a food to which they are allergic despite efforts to avoid it.

Food allergies occur when the immune system reacts abnormally to certain foods, sometimes producing a severe response called anaphylaxis where the immune system releases chemicals that may cause the body to go into shock, which can be deadly. Often, rescue medications like epinephrine are used during a reaction, but until now there has been no approved treatment to help stop these reactions from occurring after accidental exposure to multiple foods. However, omalizumab is not a rescue medication and patients should continue avoiding their allergens.

The research described in this press release was funded by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Center for Advancing Translational Sciences, both part of the National Institutes of Health, under award numbers UM2AI130836, UM1AI130838, UL1TR003098, UM1TR004408, UM1AI130570, UM1AI130839, UM1AI130936, UM1TR004406, UL1TR002535, UM1TR004399, UL1TR001878, UM1AI130781, UL1TR002378, and UL1TR003107. NIAID funds the ongoing trial with additional support from and collaboration with Genentech, a member of the Roche Group, and Novartis Pharmaceuticals Corporation. The study chair is Robert A. Wood, M.D., the Julie and Neil Reinhard Professor of Pediatric Allergy and Immunology and director of the Pediatric Clinical Research Unit at the Johns Hopkins University School of Medicine. The research reported in this press release is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. Omalizumab was originally approved for the treatment of asthma. The reported outcomes for the key secondary endpoints at a threshold of ≥1000 mg was 67% for egg, 66% for milk, 75% for wheat, 41% for cashew, 64% for walnut and 65% for hazelnut. To learn more, visit choa.org/foodallergy.