FDA approves Xolair as first and only medicine for food allergies

 

• Approval is based on data from the NIH-sponsored Phase III OUtMATCH study, which showed a significantly higher proportion of food allergy patients as young as 1 year treated with Xolair could tolerate small amounts of peanut, milk, egg and cashew without an allergic reaction, compared to placebo
• More than 40% of children and more than half of adults with food allergies have experienced a severe reaction at least once1,2
• Detailed OUtMATCH results will be featured in a late-breaking symposium at the 2024 AAAAI Annual Meeting

 Novartis announced today that the US Food and Drug Administration (FDA) has approved Xolair® (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy. People taking Xolair for food allergies should continue to avoid all foods they are allergic to (commonly referred to as "food allergen avoidance"). Xolair should not be used for the emergency treatment of any allergic reactions, including anaphylaxis. Immunoglobulin E (IgE)-mediated food allergies are the most common type and are typically characterized by the rapid onset of symptoms following exposure to certain food allergens3. Xolair is the first and only FDA-approved medicine to reduce allergic reactions in people with one or more food allergies. Xolair is widely available and can now be prescribed for appropriate patients with IgE-mediated food allergy in the US. 

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