The U.S. Food and Drug Administration (FDA) has approved Xolair (omalizumab) for reducing allergic reactions, including anaphylaxis, that may occur with accidental exposure to foods in individuals aged 1 year and older with IgE-mediated food allergy. This marks a significant milestone as Xolair, produced by Genentech, a member of the Roche Group, becomes the first and only FDA-approved medicine specifically aimed at mitigating allergic reactions in people with one or more food allergies.

Genentech’s Xolair has been a beacon of hope for patients with allergic asthma for over two decades. Its recent FDA approval for use in food allergy management is based on the positive outcomes of the Phase III OUtMATCH study. This study showcased Xolair’s efficacy in significantly increasing the tolerance to allergenic foods among participants, setting a new precedent in the treatment and management of food allergies. The OUtMATCH study, funded by the National Institute of Allergy and Infectious Diseases (NIAID) and conducted at 10 clinical sites across the U.S., including Johns Hopkins Children’s Center and Stanford School of Medicine, highlighted Xolair’s potential in transforming food allergy treatment paradigms.

With an estimated 3.4 million children and 13.6 million adults in the U.S. diagnosed with IgE-mediated food allergies in 2024, the approval of Xolair comes at a crucial time. Food allergy prevalence has been on the rise, necessitating new approaches to manage the condition effectively. Xolair’s approval offers a promising new treatment option that could significantly reduce the risk of severe allergic reactions and improve the quality of life for millions of Americans living with food allergies.

Levi Garraway, Genentech’s chief medical officer, expressed optimism about Xolair’s potential to redefine food allergy management. Similarly, leaders from the Food Allergy Research and Education (FARE) and the Asthma and Allergy Foundation of America (AAFA) have lauded the FDA’s decision, underscoring the positive impact Xolair is expected to have on individuals and families affected by food allergies.

The OUtMATCH study’s results were compelling, demonstrating a statistically significant improvement in patients’ ability to tolerate allergenic foods after treatment with Xolair. The safety profile of Xolair, consistent with its use in other allergic conditions, along with the support mechanisms offered by Genentech and Novartis for accessing the treatment, underscores the comprehensive approach taken to ensure patient well-being and access to this innovative therapy.

The FDA approval of Xolair for food allergy treatment is not just a testament to the advances in medical science but also a beacon of hope for millions of Americans. As we move forward, the focus will undoubtedly shift towards ensuring access to this life-changing treatment and continuing research to further understand and combat food allergies.

  anaphylaxis, food allergies, Genentech, Levi Garraway, omalizumab, Roche Group, US FDA, USA, Xolair