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• Posted February 26, 2024

Asthma Drug Xolair Guards Against Severe Reactions in People With Food Allergies

The asthma medication Xolair has proved its prowess against food allergies, with new research showing the medication substantially lowers the chances of severe reactions in patients.

Data published Sunday in the New England Journal of Medicine and presented simultaneously at the American Academy of Allergy, Asthma and Immunology annual meeting in Washington, D.C., showed that multiple injections of Xolair (omalizumab) given over a period of several weeks slashed the severity of allergic reactions in some adults and children as young as 1 who are allergic to peanuts and other foods such as milk, eggs and wheat.

Just last week, the U.S. Food and Drug Administration expanded its approval of Xolair to include people with food allergies, based on an interim analysis of the study.

“I'm excited that we have a promising new treatment for multi-food allergic patients. This new approach showed really great responses for many of the foods that trigger their allergies,” said study senior author Dr. Sharon Chinthrajah. She's acting director of the Sean N. Parker Center for Allergy and Asthma Research at Stanford Medicine.

“Patients impacted by food allergies face a daily threat of life-threatening reactions due to accidental exposures,” added study lead author Dr. Robert Wood, director of pediatric allergy and immunology at Johns Hopkins University School of Medicine in Baltimore. “The study showed that omalizumab can be a layer of protection against small, accidental exposures.”

Chinthrajah and Wood spoke in a Stanford Medicine news release.

By including several foods in the study, the researchers were able to prove that Xolair reduced an allergic reaction even if a person were to consume multiple foods that they're allergic to at one time.

There is no cure for food allergies, and the only other FDA-approved treatment is Palforzia, an oral immunotherapy for peanut allergies in children between the ages of 4 and 17.

“There is a real need for treatment that goes beyond vigilance and offers choices for our food-allergic patients,” Chinthrajah noted.

The new study was funded by the National Institutes of Health.

Researchers enrolled 180 people with a history of peanut allergy and at least two other food allergies. Each patient was randomly assigned to either get a Xolair injection or a placebo shot every two to four weeks for 16 to 20 weeks.

When analyzing the results, the researchers looked at the 177 participants who were between the ages of 1 and 17.

“Out of our 177, 68 were ages 5 or below,” Wood told CNN, noting that before this trial, Xolair had never been studied in patients younger than 6.

“To have a large group of study participants in the very youngest age group was very meaningful,” Wood added. “We know a lot about this drug from all its years of use in asthma, but the safety of young children has not been studied, so that was an important, reassuring aspect of the study.”

A total of 118 participants were given Xolair, while 59 were given a placebo shot.

After 16 weeks of treatment, the study showed 79 of the 118 -- about 67% -- who were given Xolair were able to tolerate at least 600 milligrams or more of peanut protein, which is equal to about 2.5 peanuts. By comparison, only about 7% of participants who received placebo shots could do that.

Those who received Xolair were also more likely to tolerate other allergens such as cashew, egg and milk than the placebo group.

Still, Xolair does not come cheap: Its estimated list price ranges from about $2,900 for children to $5,000 for adults each month, according to drug maker Genentech.

“The actual cost paid by most patients is typically lower based on their insurance coverage and other financial assistance programs available,” Genentech spokesperson Lindsey Mathias previously told CNN.

More research is needed to further understand how Xolair could help people with food allergies, the researchers noted.

“We have a lot of unanswered questions: How long do patients need to take this drug? Have we permanently changed the immune system? What factors predict which people will have the strongest response?” Chinthrajah said. “We don't know yet.”

More information

Food Allergy Research and Education (FARE) has more on food allergies.

SOURCE: New England Journal of Medicine, Feb. 25, 2024; CNN