The FDA has approved omalizumab (Xolair; Novartis) 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. This approval marks omalizumab as the first and only FDA-approved medicine to reduce allergic reactions in patients with food allergies.

Patients taking omalizumab are advised to continue avoiding all foods they are allergic to, and it should not be used for emergency treatment of allergic reactions. According to Novartis, the drug is designed to protect individuals from accidental exposures, which are the primary cause of allergic reactions.

The approval is based on positive data from the phase 3 OUtMATCH study, which evaluated omalizumab’s use in individuals aged 1 to 55 years with peanut allergies and at least 2 other food allergens, including milk, eggs, cashews, wheat, hazelnuts, and walnuts. Participants in the study received 16 to 20 weeks of subcutaneous injection of omalizumab or placebo, followed by food challenges to assess their tolerance to various allergens.

Positive results from the study showed that 68% of participants in the treatment arm could tolerate at least 600 mg of protein from peanuts, indicating the potential of omalizumab to mitigate allergic reactions in patients with multiple food allergies.

Dr. Thomas Casale, professor of medicine at the University of South Florida, expressed excitement about the approval, stating, “Now to have an option where you could prevent accidental exposure-induced anaphylaxis is great. It’s unlikely that patients are going to be able to eat with impunity whatever they’re allergic to. This drug will likely protect them from those accidental exposures, which are the majority of the reactions.”