FDA Approves Drug, Tested at Emory and Children's, That Helps Reduce Allergic Reactions to Multiple Foods

ATLANTA — Approximately 8% of U.S. children suffer from food allergies, and almost half of those children have multiple food allergies. There were no approved solutions for those allergic to multiple foods — until now.

Earlier this month, the U.S. Food and Drug Administration approved injection of omalizumab, also known by the brand name Xolair, for the reduction of allergic reactions — including reducing the risk of anaphylaxis — in certain adults and children one year or older with one or more food allergies.

This approval was based on interim findings, published Feb. 25 in the New England Journal of Medicine, from a nationwide clinical trial that showed 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 could consume without an allergic reaction after exposure.

Emory University and Children’s Healthcare of Atlanta were one of 10 sites to take part in 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” — administered nationwide through the National Institute of Allergy and Infectious Diseases-funded Consortium for Food Allergy Research.

“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,” says Brian Vickery, MD, Marcus Professor of Pediatric Immunology at Emory’s School of Medicine and chief of the Division of Allergy and Immunology at Children’s.

Smaller previous studies suggested omalizumab might be effective in food allergy desensitization, but Vickery, who served as principal investigator of the Emory and Children’s study site, says the OUtMATCH trial was the first large, multicenter, randomized controlled Phase 3 trial of the drug.

The study team enrolled 177 children and adolescents ages 1-17 years and three adults ages 18-55 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 16-20 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, suggesting the therapy has the potential to reduce allerguc reaction 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.

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.

This research 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, MD, 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 at the Johns Hopkins University School of Medicine. The research reported in this publication 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.