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New Indication Alert: FDA Approves Genentech’s Xolair® (omalizumab) for Treatment of Food Allergies

Feb 16, 2024

Genentech announced that FDA has approved Xolair® for the reduction of allergic reactions, including anaphylaxis, in adult and paediatric patients aged 1 year and older with IgE-mediated food allergy.  The announcement states that Xolair® is the first FDA-approved medicine to reduce allergic reactions in people with food allergies.  The approval was based on the Phase III OUtMATCH study in patients allergic to peanuts and at least two other food allergens.  Xolair was previously FDA approved for the treatment of asthma, chronic rhinosinusitis and chronic spontaneous urticaria.  

Parent company Roche announced submission of the BLA for the food allergy indication in December 2023.  Celltrion, Glenmark and Kashiv Biosciences are reported to have omalizumab biosimilars in development.