Boy scratching his neck from cross contamination food allergy.

Food allergy therapy has taken a major step forward. The U.S. Food and Drug Administration (FDA) has approved omalizumab (Xolair®) for people with food allergies. The medication is approved for adults and children ages 1 year and older with food allergy.

Xolair allows people with food allergies to better tolerate an accidental exposure to a food allergen. It also reduces the risk of an allergic reaction.

Xolair is the first FDA-approved drug that can treat more than one type of food allergy. The drug was developed by Genentech and Novartis.

Xolair is not a cure for food allergy. People taking the medication as a food allergy therapy must continue to avoid their food allergen(s). They should also continue to carry and use epinephrine in case of a severe allergic reaction. Xolair is not a treatment for a severe allergic reaction.

For years, people with food allergies had to avoid eating foods to which they are allergic. This was considered the only way to prevent an allergic reaction. They used epinephrine to treat a severe allergic reaction. Accidental exposures can be hard to avoid, though. That’s why Xolair is an important new treatment for food allergy. The drug can help protect against an accidental exposure. It can reduce the risk of a severe allergic reaction.

“This is huge for families with food allergies,” says board-certified allergist Purvi Parikh, MD. “It’s an added layer of protection against accidental food allergy exposures.”

For some food allergy patients, omalizumab could be an alternative to OIT. OIT involves eating a small, gradually increasing amount of a food allergen. The goal of OIT is to build tolerance to the allergen. This is done in a healthcare setting only. Palforzia is an FDA-approved OIT product, but it is only for peanut allergy.

Approximately 20 million Americans have food allergies. This includes 16 million adults and 4 million children. Food allergy affects Black and Hispanic/Latino populations at higher rates than other groups. More than half of adults are at risk for severe food-allergic reactions. More than 40% of children are at risk for severe reactions due to food allergies.

How does Xolair work for food allergy?

Xolair is a biologic medication. It is in the class of drugs known as monoclonal antibodies. The medication targets and blocks the Immunoglobulin E (IgE) antibody. IgE is a driver of food-allergic reactions. Reducing IgE levels keeps the body from reacting to an allergen. Xolair prevents the release of histamine that is part of the allergic response and also stops inflammation.

Xolair is taken as an injection every 2-4 weeks. The dosage is between 75 mg to 600 mg based on body weight. Patients can receive the injection in a healthcare setting. They can also self-inject it at home if approved by their healthcare provider.

How did Xolair for food allergy perform in clinical trials?

FDA approved Xolair for food allergy based on the OUtMATCH study. The National Institutes of Health funded the research.

NIH researchers began the OUtMATCH study in 2019. It involved 168 patients ages 1 to 55 years of age. Each of the patients were allergic to peanuts and at least two other foods. They received Xolair or a placebo for 16 to 20 weeks.

Classic food-allergic reactions are triggered by IgE. Xolair targets and blocks IgE. Researchers aimed to find out if the drug can “intercept the allergic antibody.”

Researchers evaluated Xolair solely as a food allergy therapy. They also evaluated Xolair as an add-on therapy to OIT.

The OUtMATCH study showed Xolair helped improve the reaction threshold for peanut and other common food allergens. The threshold was higher for certain food allergens. A higher number of patients taking Xolair were able to tolerate 600 mg of peanut and 1,000 mg of cashew, milk and egg without moderate to severe allergic symptoms. The amount was significantly higher than what they were able to tolerate prior to taking Xolair.

Researchers determined Xolair would help protect against allergic reactions if there’s an accidental exposure.

What are Xolair side effects?

Xolair was first approved by FDA in 2003. In addition to food allergy, it can be prescribed to patients with:

  • moderate to severe asthma
  • severe chronic rhinosinusitis with nasal polyps
  • chronic spontaneous urticaria

The most common side effects of Xolair are pain at the injection site and fever. There may also be joint pain.

Xolair comes with a boxed warning for anaphylaxis. This means there is a risk for a severe allergic reaction after taking Xolair. Patients should start Xolair injections in a healthcare setting so they can be monitored and treated for an allergic reaction. Patients approved to take Xolair at home should have epinephrine available for emergency treatment.

Reviewed by:
Purvi Parikh, MD, FACAAI, is an adult and pediatric allergist and immunologist at Allergy and Asthma Associates of Murray Hill in New York City. She is on faculty as Clinical Assistant Professor in both departments of Medicine and Pediatrics at New York University School of Medicine.