Xolair Approved for Patients With Food Allergies

The US Food and Drug Administration (FDA) recently approved Xolair (omalizumab) for the reduction of allergic reactions, including anaphylaxis, after accidental exposure to one or more foods in adults and children 1 year and older with immunoglobulin E (IgE)-mediated food allergies, announced biotechnology firm Genentech, a member of the Roche Group.

The indication marks the fourth in the United States for Xolair, which was first approved in 2003. In addition to food allergy, the prescription biologic is indicated for moderate to severe persistent allergic asthma, chronic spontaneous urticaria, and chronic rhinosinusitis with nasal polyps.

Xolair is the only medicine approved to reduce allergic reactions in people with food allergies. The FDA approval is based data from the phase 3 OUtMATCH study, which included patients aged 1 to 55 years who, at baseline, were unable to tolerate up to 100 mg of peanut protein (an amount equal to about a third of a peanut) and up to 300 mg each of milk, egg, and cashew protein.

After 16 to 20 weeks of treatment, 68% of patients treated with Xolair tolerated at least 600 mg of peanut protein (equivalent to about two and a half peanuts or a half-teaspoon of peanut butter) without moderate to severe allergic symptoms, compared with 5% treated with placebo. In addition, 66% of patients treated with Xolair tolerated at least 1000 mg of protein from milk (equivalent to two tablespoons of 1% milk), 67% tolerated a quarter of an egg, and 42% tolerated about three and a half cashews without experiencing moderate to severe allergic symptoms. Rates of exposure without moderate to severe allergic symptoms in patients treated with placebo were 11%, 0%, and 3%, respectively.

While patients in the study tolerated specific, small amounts of these foods, treatment with Xolair should be combined with continued food allergen avoidance, Genentech advised. Xolair should not be used for emergency treatment of allergic reactions.

The recommended dosage for patients with food allergy is 75 mg to 600 mg once every 2 or 4 weeks. Specific doses and frequency depend on total serum IgE level and body weight.

Reference

FDA approves the first and only medicine for children and adults with one or more food allergies. News release. Genentech; February 16, 2024. Accessed March 5, 2024. https://www.gene.com/media/press-releases/15019/2024-02-16/fda-approves-xolair-as-first-and-only-me