FDA Approves XOLAIR to Treat Children and Adults With One or More Food Allergies

Genentech announced on February 16, 2024, that the U.S. Food and Drug Administration (FDA) approved XOLAIR (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with Immunoglobulin E (IgE)-mediated food allergy.  XOLAIR was initially approved by the FDA in 2003.  This marks the fourth FDA-approved indication for XOLAIR across allergic and inflammatory conditions, including moderate to severe persistent allergic asthma, chronic spontaneous urticaria (CSU), and chronic rhinosinusitis with nasal polyps (CRSwNP). According to Genentech, XOLAIR is the first and only FDA-approved medicine to reduce allergic reactions in people with one or more food allergies.

The FDA approval is based on positive data from the National Institute of Health (NIH) sponsored Phase III OUtMATCH study, which evaluated XOLAIR in patients aged 1 to 55 years allergic to peanuts and at least two other food allergens, including milk, egg, wheat, cashew, hazelnut, and walnut.  The study showed that a significantly higher proportion of food allergy patients as young as 1 year treated with XOLAIR could tolerate small amounts of peanut, milk, egg, and cashew without an allergic reaction, compared to placebo.