FDA Priority Review Granted to Omalizumab for Adults, Children with Food Allergy

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The decision by the FDA is a step closer to omalizumab’s potential approval, making it the potential first medicine to reduce reactions to many different food allergens after accidental exposure.

Roche announced that the US Food and Drug Administration (FDA) gave Priority Review to their supplemental Biologics License Application (sBLA) for omalizumab (Xolair), with the treatment designed to help reduce severe reactions to accidental exposure to one or more food allergens.1

If the drug were approved, omalizumab would treat both adult and pediatric individuals aged 1 year and above that have food allergies. If the drug were approved, Those under treatment would still be required to avoid allergenic foods, a practice most widely known as “food avoidance.”

“Despite the significant and growing health burden from food allergies, treatment advances have been limited,” Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development, said in a statement. “We are proud to partner with the National Institutes of Health and leading research institutions on this groundbreaking study."

Garraway also commented that the FDA’s Priority Review designation acknowledges the existence of an unmet need for those suffering from severe food allergies, adding that he hopes the drug can be made widely-available in the future.

The acceptance by the agency of this submission was grounded on the promotion of interim analysis outcomes from the first phase of the National Institutes of Health (NIH)-sponsored pivotal phase 3 OUtMATCH study. This trial looked at omalizumab’s use in subjects allergic to peanuts and a minimum of 2 other common food products.

If the drug were sanctioned by the FDA, it would be the first one to treat allergic reactions to multiple different food products after instances of unintended exposure. The FDA is also anticipated to render a decision regarding an approval in the initial quarter of 2024.

In the interim analysis, an independent Data and Safety Monitoring Board (DSMB) looked at information regarding the initial 165 children and adolescents taking part in the first stage of the OUtMATCH trial. The investigators ended up finding that the research fulfilled its primary and its key secondary endpoints.

The findings specifically indicated that those in the omalizumab arm, compared to those in the placebo arm, saw large increases in the levels of peanut (primary endpoint), milk, egg and cashew (key secondary endpoints) needed to result in an allergic reaction. The team found that the safety findings also aligned with the benefit-risk profile of omalizumab that had been established across its approved indications and prior clinical research.

Omalizumab is currently approved by the FDA for the treatment of moderate-to-severe cases of chronic spontaneous urticaria, persistent allergic asthma, and chronic rhinosinusitis with nasal polyps.

An approval for those with food allergies could provide a new option for the up to 17 million people in the US with such allergies. Prevalence has been steadily rising over the past 2 decades, with over 40% of children and more than half of US adults in this category having reported experiences of severe reactions.


  1. FDA grants priority review to Xolair (omalizumab) for children and adults with food allergies based on positive National Institutes of Health phase III study results. GlobeNewswire. December 19, 2023.,allergic%20reactions%2C%20including%20anaphylaxis%2C%20that. Date accessed: December 19, 2023.