New FDA-Approved Drug Offers Hope for Children with Multiple Food Allergies

Approximately 8% of U.S. children suffer from food allergies, with almost half experiencing allergies to multiple foods. Until recently, there were no approved solutions for those allergic to multiple foods. However, a breakthrough has emerged.

The U.S. Food and Drug Administration (FDA) recently approved the use of omalizumab, also known as Xolair, for reducing allergic reactions, including the risk of anaphylaxis, in certain adults and children with one or more food allergies.

This approval follows interim findings published in the New England Journal of Medicine on February 25th, based on a nationwide clinical trial. The trial, known as OUtMATCH (Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Children and Adults), involved 10 sites across the United States, including Emory University and Children’s Healthcare of Atlanta.

Dr. Brian Vickery, the Marcus Professor of Pediatric Immunology at Emory’s School of Medicine and chief of the Division of Allergy and Immunology at Children’s, expressed optimism about the approval, stating, “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 OUtMATCH trial, led by Vickery, enrolled 177 children and adolescents along with three adults with confirmed allergies to peanut and at least two other common foods. Participants received either omalizumab or a placebo and were subsequently challenged to see if they could tolerate larger amounts of food without experiencing allergic reactions.

Results indicated that nearly 67% of participants who completed omalizumab treatment could consume about 2.5 peanuts without a severe allergic reaction, compared to less than 7% of those who received the placebo. Similar outcomes were observed for other allergens like egg, milk, wheat, cashew, walnut, and hazelnut.

Food allergies can trigger severe responses, including anaphylaxis, which can be life-threatening. Omalizumab offers a potential lifeline for patients, reducing the risk of allergic reactions following accidental exposure to allergens.

However, it’s important to note that omalizumab does not replace the need for patients to avoid foods they are allergic to. The drug is intended for repeated use to reduce the risk of allergic reactions and is not meant for immediate emergency treatment of allergic reactions, including anaphylaxis, according to the FDA.