FDA Approves Omalizumab as First Treatment of 1 or More Food Allergies for Children, Adults

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The approval is based upon phase 3 findings from the OUtMATCH study, representing the first treatment for adult and pediatric patients with accidental exposure to 1 or more food allergens.

The US Food and Drug Administration approval of omalizumab (Xolair) was announced by Novartis for treatment reactions such as anaphylaxis resulting from exposure to 1 or more food allergens in both adult and children 1 year of age and older that have immunoglobulin E (IgE)-mediated food allergies.1

The FDA’s decision is significant as omalizumab represents the first and, so far, only treatment approved by the agency for patients with 1 or more IgE-mediated food allergies. Such allergies are the most common form and often lead to the rapid onset of allergic symptoms after exposure to specific allergens found in foods.

"The stress of living with food allergies can weigh heavily on people and their families, particularly when navigating events like children's birthday parties, school lunches, and holiday dinners with friends and family," Kenneth Mendez, CEO and president of the Asthma and Allergy Foundation of America (AAFA), said in a statement. "Given the growing prevalence of food allergies, this news offers hope to the many children and adults who may benefit from a new way to help manage their food allergies."

The February 16 decision follows the favorable data which had resulted from the phase 3 OUtMATCH study, assessing the treatment’s use among individuals aged 1 to 55 years with peanut allergies and allergies to at least 2 other food allergens. Some of these included eggs, milk, cashews, wheat, hazelnuts, and walnuts.

Recruited participants from OUtMATCH initially were given 16 - 20 weeks of subcutaneous injection of omalizumab or placebo, with each subject being given 4 food challenges and gradual increases in allergic food amounts (or a placebo ingredient) to assess whether they could consume, without moderate to severe allergic symptoms, a single dose of at least 600 mg of peanut protein (primary endpoint) and a dose of at least 1,000 mg of egg, milk, or cashew protein (secondary endpoints).

The investigators found that 68% of OUtMATCH participants in the treatment arm for 16 - 20 weeks could tolerate at least 600 mg of protein from peanuts without such allergic symptoms, versus 5% among those in the placebo arm (P < 0.0001).

Additionally, the research team found that a far greater proportion of those treated with omalizumab compared to those given a placebo were able to tolerate 1,000 mg minimum of protein found in egg (67% compared to 0%; P < 0.0001), milk (66% compared to 11%; P < 0.0001), or cashew (42% compared to 3%; P < 0.0001) without the same allergic symptoms.

The investigators did note, however, that those with allergies must continue to maintain avoidance of food allergens while undergoing treatment with omalizumab.

The team added that the most common adverse events, seen in ≥3% of subjects, were shown to be injection site reactions (15.5% compared to 10.9% given placebo) and fever (6.4% compared to 3.6% given placebo). The OUtMATCH study’s safety findings were in line with the treatment’s existing safety profile over its other types of indications and observed in prior studies.

A late-breaking symposium at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting will feature some of the data. The approval is the fourth such indication for omalizumab for the treatment of allergic and inflammatory conditions, some others of which have been chronic spontaneous urticaria (CSU), allergic asthma, and chronic rhinosinusitis with nasal polyps.

"Many people with food allergies and their loved ones live in constant fear of accidentally coming into contact with the food they are allergic to and the life-threatening allergic reaction that could happen as a result,” Reshema Kemps-Polanco, executive vice president and Chief Commercial Officer of Novartis US, said in a statement. “Today's approval of (omalizumab) represents a paradigm shift in the way food allergies can be managed.”


  1. FDA approves Xolair® (omalizumab) as first and only medicine for children and adults with one or more food allergies. Novartis. February 16, 2024.,patients%20aged%201%20year%20and. Date accessed: February 16, 2024.