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Windom Allergy, Asthma, Sinus

Omalizumab approved for food allergy – is it really a big deal?


Here at Windom Allergy we are always excited to hear news about food allergy, but what’s new about a biologic that’s been on the market since 2003? Omalizumab (Xolair, an injectable medication that blocks the allergy antibody, IgE) first came out as a drug for asthma. We were one of the clinical research sites that tested the drug in our patients in the late 90’s, at the time in an intravenous form. It came to market as a subcutaneous shot, now in a convenient self-injecting syringe for home use. Once a drug is on the market, curious clinicians in concert with proactive patients will use medications off-label when they think it will help. Have allergists been trying to get their food allergy patients on omalizumab over the past 20 years, or were they pushing the manufacturer to seek FDA approval for food allergy? No, so how did we get here?

As pharmaceutical companies routinely do to squeeze out as much revenue as possible for an approved drug, new indications for omalizumab have been pursued over the years. In 2006, a study was performed using omalizumab in conjunction with starting allergy shots for patients with environmental allergies. Allergy shots have been in use since the 1930’s for seasonal and year-round allergy sufferers. Adding an expensive biologic to make a safe and effective treatment of allergy shots a little bit safer, was met with deaf ears by the allergy community. 

In 2016 omalizumab was approved for urticaria (hives) and more recently it was approved for nasal polyps. Yet, over all this time the company’s suite of MBA’s and market analysts never saw an opportunity in the food allergy space. It was not until the National Institutes of Health (NIH) offered to sponsor the OutMatch trial did the company find themselves with a wonderful gift package at their front door (paid for by you, the American taxpayer). The study was carried out at the leading allergy research universities and published in the New England Journal of Medicine in February, 2024. While the academic doctors go back to their other research projects, the fanfare generated by the news of treating food allergy with omalizumab will be pushed to the hilt by omalizumab’s marketing team.

What are allergists and food allergy patients to do with this ‘news’? We need to look beyond the headlines, appreciate the hard work put in by the OutMatch study volunteers and study sites, and evaluate the role for this drug, if any. Omalizumab costs ~$2,000/injection and is taken every 2-4 weeks. While on it, IgE antibodies are reduced, including the ones ready to react to peanut, cashew, etc. The patient becomes less sensitive to the food, but must still practice avoidance because the degree of protection is inconsistent and severe anaphylactic reactions can still occur. Once the drug is stopped, the allergy antibodies return and you’re back to square one.

Is there a better solution to managing severe food allergy? Absolutely. Similar to the way allergy shots (subcutaneous immunotherapy, SCIT) make our ragweed, dust mite, cat, and oak pollen patients feel so much better, through a process called desensitization, food allergy patients can become desensitized to food via oral or sublingual immunotherapy (OIT and SLIT). Small amounts of the food are given orally or under the tongue on a daily basis, with gradual increases in the amount of food over time. This process shifts your immunologic make-up from an allergic profile to one of a non-allergic individual. For many people this is long lasting, especially if you continue to consume the food at least 1-2 times a week. It is this natural approach to overcoming food allergy that we are big fans of here at Windom Allergy. Every food allergy patient is unique and treatment options should be reviewed with the patient and family. We are always happy to offer our input via a telehealth or in-person visit with one of our board-certified Allergists/Immunologists.

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