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FDA Approves First Medication to Help Reduce Allergic Reactions to Multiple Foods After Accidental Exposure (www.fda.gov)

The FDA has approved Xolair (omalizumab) for immunoglobulin E (IgE)-mediated food allergy in adults and children one year or older to reduce risks of allergic reactions, including anaphylaxis, upon accidental exposure to allergens. This approval marks Xolair as the first medication for the reduction of allergic reactions to multiple food types. The drug must be used repeatedly and is not a substitute for emergency treatment of allergic reactions. Its efficacy was demonstrated in a significant study showing a majority of subjects could consume foods without moderate to severe allergic symptoms after treatment. Xolair has been previously approved for other allergic conditions and comes with specific safety warnings and precautions.
Main Points
- FDA approval of Xolair for food allergy management.The FDA approved Xolair (omalizumab) injection for reducing allergic reactions including anaphylaxis in certain adults and children aged 1 year or older after accidental exposure to food allergens. Xolair is intended for repeated use and not for emergency treatment.
- Xolair: first drug for multi-food allergy reduction.Originally approved in 2003 for allergic asthma, Xolair is now the first drug to be FDA-approved for reducing allergic reactions to multiple foods.
- Mechanism and precautions of Xolair.Xolair binds to IgE, blocking it from triggering allergic reactions. It comes with a boxed warning for anaphylaxis and other side effects like fever and joint pain.
- Study results prove Xolair's efficacy.In a key study, 68% of Xolair-treated subjects were able to eat peanut protein without severe allergic reactions, showing its efficacy.
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