FDA Grants Priority Review to Xolair (Omalizumab) for Reduction of Allergic Reactions to Multiple Foods

On December 19, Roche announced that the FDA had accepted its supplemental Biologics License Application (sBLA) for Xolair (omalizumab) to reduce allergic reactions, including anaphylaxis, caused by accidental exposure to one or more foods in adults and children aged one year and older. This sBLA has also been granted Priority Review, with the FDA expected to make a decision in the first quarter of 2024. If approved, Xolair would become the first drug available to reduce allergic reactions caused by multiple foods.

Omalizumab is a humanized monoclonal antibody targeting human immunoglobulin E (IgE) produced using recombinant DNA technology in Chinese hamster ovary cells. Currently, the drug has been approved for the treatment of chronic idiopathic urticaria, chronic rhinosinusitis with nasal polyps, asthma, and other indications. In the United States, Genentech, a subsidiary of Roche, and Novartis jointly oversee the development and promotion of Xolair.

This application acceptance is based on the interim analysis results of the first phase of the pivotal Phase III OUtMATCH study sponsored by the National Institutes of Health (NIH), which evaluated the efficacy of Xolair in patients allergic to peanuts and at least two other common foods.

In a pre-planned interim analysis, the Independent Data and Safety Monitoring Board (DSMB) evaluated data from 165 children and adolescents aged 1-17 and determined that the study met its primary and key secondary endpoints. The results showed that, compared to placebo, Xolair significantly increased the amount of peanuts (primary endpoint) as well as milk, eggs, and cashews (key secondary endpoints) required to trigger allergic reactions in children and adolescents.

In the United States, food allergies affect up to 17 million children and adults. Over the past 20 years, the prevalence of food allergies has been on the rise. The severity of allergic reactions can range from mild to moderate (including hives and swelling) to life-threatening, such as anaphylaxis. More than 40% of children and over half of adult food allergy sufferers have experienced at least one severe allergic reaction. It is estimated that in the United States, there are as many as 30,000 emergency room visits annually for food-related allergic reactions.

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