Pharma

FDA approves food allergy medication that reduces harmful reactions after accidental exposure

Xolair injections can reduce the risk of allergic reactions, including anaphylaxis, for patients with Type 1 hypersensitivities.
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Good news for anyone with a peanut allergy who ate a sneaky Reese’s in their trail mix (or their iced coffee or their chocolate ice cream shell or...): A modern-day medication may keep those dreamy moments from turning into a nightmare.

This month, the Food and Drug Administration (FDA) approved Xolair (omalizumab) for the reduction of allergic reactions following accidental exposure to food allergens. Xolair is an injectable that is meant to be taken repeatedly over a few weeks, and over time, can reduce the risk of severe reactions—including anaphylaxis—to certain food allergens like peanuts, milk, and eggs.

These foods can trigger immunoglobulin E-mediated (IgE) reactions, which are characterized by rapid symptom onset—such as anaphylaxis, asthma, and rhinitis—after ingestion. Xolair is an anti-IgE monoclonal antibody, which binds to IgE antibody types and prevents them from binding to their receptors and triggering allergic reactions.

According to the FDA, a study found Xolair to be safe and effective through a clinical trial in which researchers randomly gave pediatric and adult participants either Xolair or a placebo medication for 16 to 20 weeks. Compared to those who received a placebo, 68% of subjects who received Xolair were able to eat a single dose (600 milligrams or greater, or about 2.5 peanuts’ worth) of peanut protein “without moderate to severe allergic symptoms,” compared to just 6% of placebo subjects at the end of the study.

Other effective allergen reductions included cashew (which 42% of Xolair subjects were able to ingest without moderate to severe allergic symptoms, compared to 3% of the placebo group), milk (66% of Xolair versus 11% of placebo), and egg (67% of Xolair versus 0% of placebo). It’s important to note that, unlike epinephrine, Xolair is not approved for emergency treatment of allergic reactions.

“While [Xolair] will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs,” Kelly Stone, an associate director in the FDA’s Center for Drug Evaluation and Research, said in a statement.

The price of Xolair, which is produced by Roche and Novartis, ranges from about $2,900 a month for children to $5,000 a month for adults, according to Genentech.

According to the US Department of Agriculture, it’s estimated that severe reactions to food allergies cause 30,000 emergency room visits, 2,000 hospitalizations, and 150 deaths a year in the US.

The referenced clinical trial on Xolair’s efficacy is still ongoing, with an estimated study completion date of 2026. So you can start exploring the wide world of Reese’s—but maybe hold off on eating them just yet.

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Healthcare Brew covers pharmaceutical developments, health startups, the latest tech, and how it impacts hospitals and providers to keep administrators and providers informed.