Xolair Takes Step Toward FDA Approval for Multiple Food Allergies

in Food Allergy, Food Allergy News
Published: December 20, 2023

The use of Xolair as a treatment to protect from allergic reactions to multiple foods has moved a step closer to Food and Drug Administration approval. [March 2024 update: Xolair is now approved to treat food allergies. Approval article is here.]

The drug’s makers announced on Dec. 19, 2023 that the FDA has granted priority review to its application for a supplemental biologics license for omalizumab (Xolair) as a food allergy treatment in patients ages 1 and older.

Girl with her mom and female allergist.
Photo: Getty

The FDA’s move is based on positive findings from the first 165 children and teens who participated in a controlled trial, called OUtMATCH. The Phase 3 trial found that allergic children who got omalizumab injections could consume significantly higher doses of peanut, egg, milk and cashew before starting to react than allergic kids who received placebo injections.

Those taking omalizumab would still be told to avoid their allergens. However, the medication would reduce their risk of serious reactions, including anaphylaxis, due to accidental exposures to small amounts of the food.

If the FDA approves its use in food allergy, omalizumab would become the first “anti-IgE” biologic drug for reducing reactions to multiple food allergens.

Omalizumab is an injectable biologic medication that helps to neutralize IgE antibodies. It’s already approved to treat moderate to severe asthma, chronic hives and nasal polyps.

“Despite the significant and growing health burden from food allergies, treatment advances have been limited,” said Dr. Levi Garraway in a statement. He’s chief medical officer and head of Global Product Development for Genentech. Genentech and Novartis Pharmaceuticals are the co-developers of Xolair.

“The FDA’s Priority Review designation acknowledges the unmet need for these patients, and we hope to make Xolair available to as many people as possible living with food allergies in the U.S.,” Garraway said. The company expects the FDA’s decision in the first quarter of 2024.

Solo Therapy for Multiple Allergies

The OUtMatch trial is funded by the National Institute of Allergy and Infectious Diseases. Researchers from the Consortium of Food Allergy Research from the consortium are conducting the study at 10 sites across the U.S.

The trial was launched in 2019, after the FDA granted omalizumab breakthrough therapy designation as a potential food allergy treatment.

The trial includes several stages. Stage 1 looks at Xolair as a standalone treatment for multiple food allergies. Stage 2 looks at Xolair as an add-on therapy to improve the safety and reduce reactions during to oral immunotherapy (OIT).

The Stage 1 results are what the company is sharing preliminary data on now. In that stage, patients received six months of Xolair shots or placebo shots every two to four weeks, and then underwent oral food challenges.

In the active study arm, depending on how much of their allergens participants could tolerate, kids could then either start introducing those foods into their diet, or start multi-allergen OIT.  

Those who had a lot of the food at their oral challenge without reacting were given a minimum and a maximum amount of the allergenic foods to consume daily. That’s to maintain desensitization. Those who reacted to smaller amounts of the food were offered OIT, which starts at a lower dose of protein.

In an interview with Allergic Living in 2022, Dr. Robert Wood, the study’s primary investigator, described early trial results. “What we can say, even though the results are not fully analyzed, is that most of the participants were able to successfully introduce the foods they were allergic to into their diet,” Wood said. The allergist is director of pediatric allergy and immunology at Johns Hopkins Medicine in Baltimore.

Stage 1 of the trial had a goal of 225 patients. According to Genentech, an independent data and safety monitoring board recommended halting enrollment into the first stage of the trial based on “favorable results.”

Xolair Study and OIT

Stage 2 of the Xolair food allergy trial is ongoing. In OIT, people with food allergies gradually build up their tolerance to their allergens by eating increasing amounts of their allergen, daily over the course of weeks or months.

Participants in Stage 2 will receive omalizumab injections for the first eight weeks of treatment, then start either multi-allergen OIT or placebo OIT.

FDA approval would help clear the way for insurance coverage for use as a food allergy treatment, Wood has noted.

  • The FDA granted priority review to omalizumab (Xolair) for reducing allergic reactions in patients ages 1 and up with multiple food allergies.
  • Those taking Xolair would still need to avoid foods they are allergic to. But the medication would help prevent from reactions due to accidental exposures to small amounts of the food.
  • The FDA’s decision is based on promising results from a trial that involves 165 children and teens. The study found kids receiving Xolair injections could eat far higher doses of peanut, egg, milk and cashew before starting to react than children who received placebo injections.

Related Reading:
Earlier Article: Could Xolair Be First Biologic Therapy for Food Allergies?
OIT for Multiple Allergens Shows Promise in Early Results