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New Horizon in Food Allergy Treatment: FDA Approves Xolair for All Ages


16 February 2024

The FDA has given full approval to Xolair® for treating individuals aged 1 and older with IgE-mediated food allergies, marking it as the first medication for this condition. Based on the NIH-sponsored Phase III OUtMATCH study, Xolair significantly increased tolerance to allergens like peanuts and milk.

Novartis announced that the US Food and Drug Administration (FDA) has approved Xolair® (omalizumab) as the first and only medication for treating food allergies. Xolair® can be used to reduce allergic reactions, including anaphylaxis, to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy. This monumental approval heralds a new era in the management and treatment of food allergies, a condition that has been a significant source of anxiety and danger for millions.

“This newly approved use for Xolair will provide a treatment option to reduce the risk of harmful allergic reactions among certain patients with IgE-mediated food allergies,” said Kelly Stone, M.D., Ph.D., associate director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research. “While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs.”  

The approval stems from robust data showcased in the Phase III OUtMATCH study, sponsored by the National Institutes of Health (NIH), which revealed a significantly higher proportion of patients treated with Xolair could tolerate small amounts of common allergens like peanuts, milk, egg, and cashew without triggering an allergic reaction, compared to those who received a placebo.

Reshema Kemps-Polanco, Executive Vice President and Chief Commercial Officer at Novartis US, emphasized the transformative potential of Xolair, noting, "Many people with food allergies and their loved ones live in constant fear of accidentally coming into contact with the food they are allergic to and the life-threatening allergic reaction that could happen as a result. Today's approval of Xolair represents a paradigm shift in the way food allergies can be managed."

Over 40% of children and more than half of the adult population with food allergies have experienced a severe allergic reaction at least once, highlighting the acute need for effective treatment options. Xolair's availability is a beacon of hope, offering a novel approach to managing a condition that affects approximately 3.4 million children and 13.6 million adults in the US alone.

The FDA's endorsement is based on the compelling outcomes of the OUtMATCH study, which evaluated the efficacy of Xolair in a diverse age group ranging from 1 to 55 years old, allergic to peanuts and at least two other food allergens. The study's results were so significant that they will be featured in a late-breaking symposium at the upcoming 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.

Xolair's mode of action involves targeting and blocking IgE, a key player in the allergic response, offering a reduction in allergic reactions for those with IgE-mediated food allergies. However, it is crucial to note that Xolair is not intended for the emergency treatment of allergic reactions, including anaphylaxis. Individuals on this treatment are advised to continue avoiding foods they are allergic to. The approval of Xolair is not just a medical milestone; it's a transformative development that promises to alleviate the constant fear and anxiety associated with food allergies.

About the OUtMATCH Study

The OUtMATCH study, a comprehensive, NIH-sponsored trial, explored the safety and effectiveness of Xolair in treating food allergies in individuals aged 1 to 55. This multi-center, placebo-controlled study involved patients allergic to peanuts and at least two other allergens, undergoing Xolair or placebo injections over 16 to 20 weeks. Participants then faced food challenges with increasing allergen doses to evaluate their tolerance levels. Conducted across 10 US sites, including Johns Hopkins and Stanford, the study aimed to assess Xolair's potential to significantly improve food allergy management.


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