FDA Clears Xolair as Sole Treatment for Food Allergies in Children and Adults

FDA Clears Xolair as Sole Treatment for Food Allergies in Children and Adults

Genentech, a member of the Roche Group, disclosed today that the U.S. Food and Drug Administration (FDA) has granted approval for Xolair® (omalizumab) to mitigate allergic reactions, including anaphylaxis, resulting from accidental exposure to one or more food items in both adult and pediatric patients aged 1 year and above with IgE-mediated food allergy. It is emphasized that individuals using Xolair for food allergies must continue to avoid all allergenic foods. Xolair is not intended for the emergency treatment of allergic reactions, including anaphylaxis. IgE-mediated food allergies, typically characterized by swift symptom onset upon exposure to specific food allergens, are the most prevalent type. Xolair marks the first and only FDA-approved medication aimed at lessening allergic reactions in individuals with one or more food allergies. It is readily accessible and can now be prescribed for suitable patients with IgE-mediated food allergy in the U.S.

Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development at Genentech, commented, “Xolair offers patients and families an important new treatment option that can help redefine the way food allergies are managed and reduce the often-serious allergic reactions that can result from exposure to food allergens.” He further added, “Today’s approval builds on 20 years of patient experience and an established efficacy and safety profile since Xolair was first approved in allergic asthma. We look forward to bringing this treatment to the food allergy community who have long awaited an advancement.”

The FDA’s decision is backed by positive data from the Phase III OUtMATCH study, which assessed 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 results will be presented in detail at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting on February 25.

The study demonstrated that a significantly higher proportion of patients treated with Xolair were able to tolerate certain amounts of allergenic proteins without experiencing moderate to severe allergic symptoms compared to those on placebo. The safety profile of Xolair in the study was consistent with its known profile.

Food allergies affect millions of individuals in the U.S., with prevalence on the rise over the past two decades. Xolair now holds its fourth FDA-approved indication across various allergic and inflammatory conditions. Since its initial approval in 2003, over 700,000 patients have been treated with Xolair in the U.S.

Xolair is administered as a subcutaneous injection and targets and blocks IgE, a key driver of food allergy reactions. Genentech and Novartis are dedicated to ensuring access to Xolair through patient assistance programs and comprehensive services.

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