FDA Approves Xolair (Omalizumab) for Reducing Severe Outcomes from Multiple Food Allergies

The U.S. Food and Drug Administration (FDA) has granted approval for Xolair (omalizumab) to reduce allergic reactions, including anaphylaxis, associated with one or more food allergies among individuals aged 1 year and above. Developed jointly by Genentech and Novartis, Xolair is the first FDA-approved medicine specifically targeting multiple food allergies. Patients must still avoid all foods they are allergic to despite using Xolair, which is not meant for emergency treatment of allergic reactions. Key points include:

- **Indication**: Xolair is indicated for reducing allergic reactions due to accidental exposure to one or more foods in adults and children aged 1 year and older with IgE-mediated food allergies.
- **Phase III OUtMATCH Study Results**: Positive data from the Phase III OUtMATCH study led to the FDA approval, showing a significant increase in tolerance for specific foods in participants treated with Xolair versus placebo.
- **Common Side Effects**: Injection site reactions and fever are common side effects of Xolair.
- **Continuous Management**: Despite Xolair treatment, patients should maintain strict food allergen avoidance.
- **Financial Assistance Programs**: Patient support and financial assistance programs exist to help afford Xolair.
- **Self-Administration Option**: Some patients may be trained to self-administer Xolair outside the doctor's office after completing initial training with their physician.

Xolair was previously approved for treating moderate to severe persistent allergic asthma and other conditions.