New drug to treat food allergies? 

Recently, the Food and Drug Administration (FDA) approved a new medication to help treat food allergies. Find out what the medication is, how it works, and when you may see it prescribed. 

How Xolair® works

The new drug approved for the treatment of food allergies is a subcutaneous injectable called omalizumab (Xolair®). It is designed to reduce the severity of allergic reactions and raise the threshold of how much allergen exposure is required to elicit a reaction. XolairÒ is not a green light for patients to freely consume their allergenic foods. Rather, patients should still make every effort to eliminate or limit confirmed food allergens in their diets.  

Xolair® treats multiple food allergens, not just one specific allergen. The medication is a monoclonal anti-IgE-antibody that is designed to be taken every two or four weeks to reduce the risk of allergic reactions over time. It is not intended to be used for emergency treatment of an allergic response.  

Who is Xolair® for?

Xolair® is FDA approved for patients 1 year of age and older with IgE-mediated food allergies. 

Clinical trials

The OUtMATCH trial is a three-phased study. In the first phase, participants with peanut allergy and at least two other food allergies were randomized to receive either omalizumab or placebo. Food allergies were confirmed by eliciting an allergic reaction after exposure to a small amount of food allergen. In this first phase, researchers wanted to determine if participants who received omalizumab could consume higher amounts of their food allergens without eliciting an allergic reaction. Of note, the median age for participants in phase one of the trial was seven years old. 

Participants who received omalizumab for 16 weeks were able to consume higher amounts of food allergens without significant allergic symptoms. The allergenic foods tested were peanuts, cashews, eggs, milk, walnuts, hazelnuts, and wheat. Thresholds to produce an allergic reaction were raised for peanuts, cashews, eggs, and milk. 

Future research

For the second and third phases of this trial, researchers from the OUtMATCH trial are planning to replicate this study and dose omalizumab for a year to observe results. After that, they hope to study if the drug can have an impact on ongoing, regular consumption of allergenic foods. 

Real-world implications

The development and approval of this drug is certainly significant for the management of food allergies, especially in children when accidental exposure is more common than with adults. An increased threshold of allergic response could even be lifesaving. However, from a nutrition perspective, the management of food allergies has not changed. At this time, total avoidance of the allergenic food is still recommended and required, even when taking the new medication. RDNs still play a vital role in helping individuals and families navigate nutrition interventions for food allergy management.  

Reference:  

Wood RA, Togias A, Sicherer SH, et al. Omalizumab for the Treatment of Multiple Food Allergies. N Engl J Med. 2024;390(10):889-899.