First-Ever Drug Approved to Prevent a Condition Affecting 20 Million Americans

Updated: Feb. 21, 2024

This nod from national authorities creates a medical milestone that may provide relief from worry and panic for families, educators of children, and adults of all ages.

In January 2024, a 25-year-old dancer from England made headlines when she ate a cookie that, unbeknownst to her, contained peanuts. She went into anaphylactic shock and expired, despite administering her epinephrine injector. It was reported she was aware that she had a life-threatening peanut allergy and faithfully checked her food labels.

In this case, the cookie package had been mislabeled. While this was a high-profile case, it’s certainly not the only time an allergic reaction, even with the use of an epinephrine injector and prompt medical attention, has led to death.

The Allergy & Asthma Network suggests 16 million adults and 4 million children in the US have at least one food allergy, while 2019 data published in a journal from the American Medical Association estimated that this figure may fall affect closer to 50 million. The FDA estimates that about 6% of people in the U.S. have a food allergy.

On February 16, 2024, the Food and Drug Administration (FDA) approved a potentially lifesaving medication in the treatment of serious food allergies.

Called Xolair, or omalizumab generically, the drug had been previously approved to treat asthma and chronic hives. It is an injection that may be taken regularly to prevent severe complications or death after accidental ingestion by individuals with an immunoglobulin E-mediated food allergy, which is a food allergy that attacks the immune system.

The FDA’s “Highlights of Prescribing Information” states that patients as young as one year of age can take the medication every two to four weeks to prevent allergic reactions. Other details and indications can be found within the document.

Treatment with Xolair is intended to reduce the cases of severe allergic reactions needing treatment with a product like an EpiPen. The medication was tested with a dose of peanuts, and 68% of people taking the medication could eat the peanuts without a severe reaction, compared to just 6% with a placebo. Testing with milk and eggs led to similar results.

However, the medication didn’t work for all people with tested allergies, so avoidance is still the recommended course of action for a food allergy. Commented Kelly Stone, MD, PhD, associate director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research: “While it 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.”

The FDA recognizes nine foods as major allergens:

  • milk
  • eggs
  • fish
  • shellfish
  • tree nuts
  • peanuts
  • wheat
  • soybeans
  • sesame

If a product contains any of these ingredients, it must be labeled accordingly. However, mislabeling does happen and can lead to tragic results.

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The approval of Xolair may come as welcome news for millions of Americans, including many parents. As one reason, a 2018 study in the Journal of Asthma and Allergy noted several significant barriers for epinephrine injectors. For one, they can be prohibitively expensive with costs reaching into the hundreds even with insurance. Plus, they must be kept onhand all the time, but can degrade in extreme temperatures and they expire quickly. They also are regularly misused or underutilized.

Experts say Xolair won’t reduce the need to carry such injectors, but it could reduce the need to use one and potentially save lives.