FDA approves omalizumab to reduce allergic reactions in patients with 1 or more food allergies


The approval makes omalizumab the first and only FDA-approved medicine to reduce allergic reactions in patients with one or more food allergies.

Omalizumab (Xolair; Novartis and Genentech) has been approved by the FDA for the reduction of allergic reactions, including anaphylaxis, that can occur from accidental exposure to 1 or more foods in patients aged 1 year and older, according to a press release from Novartis.1

Omalizumab is now the first and only FDA-approved medicine to reduce allergic reactions in patients with 1 or more food allergies. Those taking omalizumab should continue to avoid all foods they are allergic to, and omalizumab should not be used for the emergency treatment of any allergic reactions, including anaphylaxis, Novartis stated.1

"Personally, I'm very excited that [omalizumab] got approved," said Thomas Casale, MD, professor of medicine, chief of Clinical and Translational Research, Allergy and Immunology, University of South Florida.

"Now to have an option where you could prevent accidental exposure-induced anaphylaxis is great. It's unlikely, very unlikely, that patients are going to be able to eat with impunity whatever they're allergic to," added Casale. "This drug will likely protect them from those accidental exposures, which are the majority of the reactions."

The approval is based on positive data from the phase 3 OUtMATCH study, which assessed omalizumab's use in individuals aged 1 to 55 years with peanut allergies and at least 2 other food allergens, including in part milk, eggs, cashews, wheat, hazelnuts, and walnuts.2

Participants were given 16 to 20 weeks of subcutaneous injection of omalizumab or placebo, with each patient given 4 food challenges and gradually increased amounts of allergic foods or placebo, to assess whether they could consume, without moderate to severe allergic symptoms, a single dose of at least 600 mg of peanut protein (primary endpoint) and a dose of at least 1,000 mg of egg, milk, or cashew protein (secondary endpoints).2

Results demonstrated that 68% of participants in the treatment arm could tolerate at least 600 mg of protein from peanuts with allergic symptoms, compared to 5% of patients in the placebo group (P < 0.0001).2

For more details on the OUtMATCH study and the FDA approval of omalizumab, visit our sister publication HCP Live®.

Thomas Casale, MD, discloses he is an advisor and consultant for Genentech and Novartis.


1. FDA approves Xolair (omalizumab) as first and only medicine for children and adults with one or more food allergies. Novartis. Press release. February 16, 2024. Accessed February 16, 2024. https://www.novartis.com/us-en/news/media-releases/fda-approves-xolair-omalizumab-first-and-only-medicine-children-and-adults-one-or-more-food-allergies

2. Smith T. FDA approves omalozumab as first treatment of 1 or more food allergies for children, adults. HCP Live. February 16, 2024. Accessed February 16, 2024. https://www.hcplive.com/view/fda-approves-omalozumab-first-treatment-of-1-or-more-food-allergies-for-children-adults

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