Progress in food allergy research continues to offer cautious hope for people living with multiple IgE mediated food allergies. In February 2024, the U.S. Food and Drug Administration approved Xolair (omalizumab) as the first medicine to help reduce allergic reactions from accidental exposure to multiple food allergens in adults and children from one year of age.

This builds on AFSA’s earlier article, A Breakthrough in Managing Severe Food Allergies, which highlighted the growing role of immune based therapies in allergy care. The FDA approval represents an important global milestone, recognising food allergy as a condition that may benefit from targeted biological treatment rather than management based only on avoidance and emergency response.

What the Approval Means

Xolair has been used for many years in South Africa and internationally to treat allergic asthma and chronic urticaria, with a well established safety record. The approval allows Xolair to be prescribed for people with IgE mediated allergies to multiple foods such as peanut, milk, egg, wheat and tree nuts.

The approval was based on results from the OUtMATCH trial, which included adults and children allergic to peanut and at least two other foods. After treatment with Xolair for several months, participants were significantly more likely to tolerate small amounts of allergenic foods without moderate to severe reactions compared with those who received placebo. This means that the risk of serious reactions from accidental exposure was reduced.

It is important for patients and families to understand the limits of this treatment:

• Xolair is not a cure for food allergy
• People must still avoid known allergens
• Emergency medication such as adrenaline must still be carried
• Xolair is not used to treat reactions during an emergency
• It is given as a regular injection to reduce overall reaction risk

Relevance for South Africa

Although this approval currently applies to the United States, it signals an important shift in how food allergy is being approached globally. It highlights the move toward immune targeted therapies and the recognition that food allergy is a complex immune condition rather than a simple intolerance.

In South Africa, regulatory review through the South African Health Products Regulatory Authority will determine any future local approval. However, these developments are highly relevant for clinicians, researchers, advocacy groups and patients, and they help guide future planning for care, access and research.

Diagnostic Research and FAST-PASE

Alongside treatment research, new laboratory based diagnostic tools such as ATANIS’ FAST-PASE® are being developed to better understand how strongly a person’s immune system reacts to allergens using blood samples rather than direct exposure. These tools are part of research efforts to improve allergy assessment and safety but are not treatments and are not used in routine clinical care.

FAST-PASE is a novel functional test to help diagnose allergy based on a proprietary engineered mast cell line. Mast cells are immune cells that play a role in the allergic reaction. Using standardised protocols, ATANIS is able to grow a virtually unlimited number of mast cells in their laboratory. When combined with patient-derived blood serum, these cells bind to the patient’s allergy-causing IgE antibodies. Upon subsequent challenge with the suspected allergen, the mast cells degranulate the way they do in the body during an allergic reaction, and this can be measured. FAST-PASE has recently shown accuracy greater than 95% in a clinical utility study for peanut allergy.

Understanding Leukotrienes in Food Allergy

Allergic reactions involve more than just histamine. The immune system also releases chemicals called leukotrienes, which contribute to inflammation, swelling, breathing difficulties and gut symptoms. Research increasingly shows that food allergy reactions involve multiple immune pathways working together.

This helps explain why newer therapies focus on regulating the immune system itself rather than only treating symptoms. By targeting IgE, a key driver of allergic reactions, treatments like Xolair aim to reduce the overall sensitivity of the immune response.

Reference Links

• AFSA previous article
• FDA approval announcement
• FDA approval letter and Roche document
• Roche media release on OUtMATCH trial
• FAST PASE research technology
• Leukotrienes overview
• Cysteinyl leukotrienes and inflammation

Patient FAQ: New Developments in Food Allergy Research

Is Xolair a cure for food allergy?

No. Xolair does not cure food allergy. It may reduce the risk and severity of allergic reactions after accidental exposure, but people with food allergies must still avoid their allergens and carry emergency medication.

Can Xolair replace adrenaline or emergency care?

No. Xolair does not treat allergic reactions in an emergency. Adrenaline remains the first line treatment for anaphylaxis and must always be carried by people at risk of severe reactions.

Who might benefit from this treatment?

Xolair has been approved in the United States for children and adults with IgE mediated allergies to more than one food. Suitability depends on medical assessment by an allergy specialist and individual clinical factors.

Is Xolair available for food allergy in South Africa?

Not currently for this indication. Regulatory approval in South Africa would need to go through the South African Health Products Regulatory Authority. AFSA will continue to monitor developments and share verified updates. In summary, it is not registered with SAHPRA for the multiple food allergy indication, but it is available and if deemed appropriate may be used by a healthcare professional for management of multiple food allergies as an off label indication with the patient’s knowledge and consent.

Does this mean people can stop avoiding their allergens?

No. Avoidance remains essential. This treatment is designed to reduce risk from accidental exposure, not allow free consumption of allergenic foods.

What is FAST PASE?

FAST PASE is a research laboratory test system being studied to better understand allergic immune responses using blood samples. It is not a treatment and is not part of routine clinical care.

Why are leukotrienes mentioned in food allergy research?

Leukotrienes are inflammatory chemicals released during allergic reactions. They help explain why reactions can affect breathing, the gut and the whole body. Research into these pathways helps scientists develop better treatments in the future.

What should patients and families do now?

Continue with current care plans, strict allergen avoidance, emergency preparedness and regular follow up with healthcare professionals. New treatments take time to move from research to local access and must always be guided by medical specialists.

Do you suggest using it with Oral Immunotherapy?

It could be useful in combination with Oral Immunotherapy if the patient is experiencing adverse effects. A course of Xolair may help during the OIT up dosing phase by reducing reactions and can then be stopped once maintenance dosage is achieved. Using it without OIT would require ongoing monthly injections and may not be affordable in many settings.

What does Xolair cost?

Xolair is widely available and costs approximately R6 400 to R12 800 per injection, depending on the dose required.