The FDA Just Approved a Drug to Treat Severe Food Allergies

The injection is the first of its kind.



The U.S. Food and Drug Administration (FDA) has approved a medication for use in treating severe food allergies, and the agency says that this injection is the first of its kind. The drug, which has the brand name Xolair, had previously been used to treat moderate to severe asthma, hives, and nasal polyps.

In a statement, the FDA said that its decision to approve Xolair (also known as omalizumab) followed a study into its safety and effectiveness in treating food allergies. In the study, 168 adults and children with peanut allergies and allergies to at least two other common food allergens were given either Xolair injections or a placebo for between 16 and 20 weeks.

By the end of the trial, 68% of the group that received the Xolair injections were able to eat the equivalent of 2.5 peanuts without developing “moderate to severe allergic symptoms.” Only three of the 55 participants in the placebo group were able to tolerate the same amount of peanut protein without developing severe symptoms. “These results are statistically significant and clinically meaningful for subjects with food allergy,” the FDA noted.

Related: How to Dine Out Safely with Food Allergies

"This newly approved use for Xolair will provide a treatment option to reduce the risk of harmful allergic reactions among certain patients with IgE-mediated food allergies," Dr. Kelly Stone, associate director of the Division of Pulmonology, Allergy, and Critical Care in the FDA's Center for Drug Evaluation and Research, said in a statement.

According to the Associated Press, allergy sufferers who wish to use Xolair — including children as young as one year old — will take it as an injection, which is given either every two or four weeks, depending on the person's body weight and level of allergic response. It is important to note that Xolair has not been approved for use in an emergency situation to treat severe allergic reactions. Allergy sufferers who begin taking Xolair should still avoid foods that trigger an allergic reaction; the drug works by reducing the risk of allergic reactions over time.

"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," Dr. Stone told NPR.

The U.S. Centers for Disease Control and Prevention (CDC) reports that, in 2021, almost 6% of Americans have food allergies that could potentially be life-threatening. Organizations that advocate on behalf of allergy sufferers were pleased with the FDA's decision.

"We've literally overnight doubled the amount of options we have to manage this disease," Erin Malawer, the founder and executive director of the AllergyStrong nonprofit told USA Today. "No matter how careful you are, these accidental exposures happen."

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