FDA approves omalizumab: Groundbreaking treatment for food allergies, including peanuts

By Stephanie Srakocic | Fact-checked by Davi Sherman
Published February 27, 2024

Key Takeaways

  • Omalizumab's FDA approval signals progress in treating food allergies, notably peanuts, promising improved safety for sufferers.

  • Johns Hopkins-led research underscores omalizumab's success in boosting tolerance to peanuts and other food allergens.

The United States Food and Drug Administration (FDA) approved injectable omalizumab (Xolair) as a treatment for moderate to severe persistent allergic asthma in 2003. On February 16, 2024, omalizumab became the first medication approved to reduce allergic reactions, including the risk of anaphylactic shock, in people one year and older who experience immunoglobulin E-mediated food allergies. This includes nut and other common food allergies. The FDA’s approval is based on a study published in The New England Journal of Medicine this week.[][]

Researchers from Johns Hopkins Children’s Center, Genentech, and Swiss pharmaceutical company Novartis led the study. Funding was provided by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and conducted by the Consortium for Food Allergy Research (CoFAR). The findings will be presented at the American Academy of Allergy, Asthma & Immunology annual meeting on February 25, 2024.

The study compared the effects of 16–20 weeks of omalizumab injections and placebo injections among 180 participants. Participants were between the ages of 1 and 55; 177 participants were 17 or younger. All study participants had a history of peanut allergy and at least two other food allergies.[]

The participants were randomly assigned to receive omalizumab or placebo injections. After 16 weeks, 66.9% of participants who received omalizumab could tolerate 600 milligrams or more of peanut protein. Only 6.8% of participants who received placebo injections could tolerate the same amount. Participants who received omalizumab also had an increased tolerance to common food allergens such as eggs, wheat, milk, and other nuts.[] 

The amounts tolerated could protect patients from reactions after accidental exposure. Six hundred milligrams of peanut protein is equal to about 2.5 peanuts. Therefore, while people with a peanut allergy would still need to avoid consuming peanuts, they would have a reduced risk of reaction after accidental exposure to a single nut. 

Many study participants were able to consume even greater quantities of peanuts. The majority of participants could tolerate about 4,000 milligrams of peanut protein, equivalent to about 15 peanuts. Almost 50% of participants could tolerate 6,044 milligrams of peanut protein or the equivalent of about 25 peanuts—much more significant than accidental exposure.[]

Omalizumab also increased tolerance to multiple common food allergens at once. 69% of participants who received omalizumab could tolerate a cumulative dose of 1,044 milligrams of two foods. About 47% could tolerate a cumulative dose of 1,044 milligrams of three foods.[]

Researchers followed 60 of the participants for another 24 weeks. They found that most participants’ reaction thresholds remained the same or increased with continued use of omalizumab. Additionally, researchers monitored for any safety concerns, especially in the youngest subjects, as omalizumab had never been studied in children as young as 1 year of age. 

Study researchers note that up to 8% of children and 10% of adults have at least one food allergy. Up to 86% of people with a food allergy are allergic to more than one food. Before the February 16, 2024, approval of omalizumab, the only drug approved for treating any food allergy was peanut (Arachis hypogaea) allergen powder-dnfp (Palforzia). Approved by the FDA in January 2020, Palforzia is only used to mitigate allergic reactions to peanut allergies; it doesn’t cause improved tolerance of any other food allergies. The drug is approved for children between the ages of 4 and 17 years and can reduce the risk of serious allergic reactions, including anaphylaxis, after accidental exposure.[][]

The study’s evidence suggests that omalizumab could substantially affect the quality of life for those with food allergies. In addition to decreasing the risk of a serious reaction from accidental exposure, this treatment could, according to researchers, potentially eliminate some of the stress and fear of accidental exposure that many people with food allergies experience daily. 

In a statement about omalizumab, Sung Poblete, PhD, RN, CEO of Food Allergy Research & Education (FARE), the nation’s largest nonprofit engaged in food allergy advocacy, said:

"I am so excited to see that Xolair [omalizumab] has been FDA-approved for food allergies. This is a massive win for our community. Patients will now have access to this new treatment opportunity. Thank you to the Genentech and Novartis teams, to the CoFAR sites who facilitated the phase three clinical trial, and most importantly, to the brave patients who have volunteered to participate in the study.”[] 

However, people using omalizumab will still need to avoid any foods they’re allergic to and continue to carry self-injectable epinephrine for emergencies. In the study, 14% of omalizumab-receiving participants could not tolerate just 30 milligrams of peanut protein. Additionally, researchers state that the study had limitations, including a lack of participant diversity. Further study of omalizumab’s effectiveness among a wider population is still needed.[]

Share with emailShare to FacebookShare to LinkedInShare to Twitter