FDA Approves Omalizumab to Reduce Food-Based Allergic Reactions in Adult and Pediatric Patients


This marks omalizumab’s fourth FDA-approved indication for allergic and inflammatory conditions, such as severe persistent allergic asthma, with its initial approval being in 2003.

The FDA has approved omalizumab (Xolair; Genentech USA) for the reduction of allergic reactions—including anaphylaxis—that may occur as a result of accidental exposure to 1 or more foods in both adult and pediatric patients who are aged 1 year and older with immunoglobulin E (IgE)-mediated food allergy. With this approval, omalizumab is the first and only medicine to be approved by the FDA that reduces allergic reactions in people with 1 or more food allergies.

Woman having different food allergies | Image Credit: Kaspars Grinvalds - stock.adobe.com

Kaspars Grinvalds - stock.adobe.com

Omalizumab is the only approved antibody that both targets and blocks IgE. It reduces free IgE, down-regulates high-affinity IgE receptors, and limits mase cell degranulation, which minimizes the release of mediators throughout the patient’s allergic inflammatory cascade. The recommended dose for food allergy treatment is 75 to 600 mg once every 2 or 4 weeks and is administered subcutaneously. The investigators emphasize that those who take omalizumab for their food allergies should continue avoiding the foods they are allergic to and that this drug is not to be used to treat emergency reactions (eg, anaphylaxis).

“[Omalizumab] offers patients and families an important new treatment option that can help redefine the way food allergies are managed and reduce the often-serious allergic reactions that can result from exposure to food allergens,” said Levi Garraway, MD, PhD, chief medical officer and head of global product development at Roche, in a press release. “Today’s approval builds on 20 years of patient experience and an established efficacy and safety profile since [omalizumab] was first approved in allergic asthma. We look forward to bringing this treatment to the food allergy community who have long awaited an advancement.”

The FDA approval comes after positive data from OUtMATCH (NCT03881696), a multicenter, randomized, double-blind, placebo-controlled phase 3 trial that evaluated the safety and efficacy in patients aged 1 to 55 years who are allergic to peanuts and at least 2 other allergens (eg, milk, egg, wheat, nuts). Patients were randomly assigned to receive either placebo or omalizumab injections either every 2 weeks or every 4 weeks, with omalizumab doses and dosing intervals determined by patients’ total serum IgE level and body weight at baseline. Further, patients enrolled in the study were unable to tolerate up to 100 mg of peanut protein, and up to 300 mg each of milk, egg, and cashew protein.

After approximately 16 to 20 weeks of treatment with either omalizumab or placebo, each participant completed 4 “food challenges,” consuming amounts of food to which they are allergic plus a placebo at gradually increasing intervals. Further, the primary end point of the study was the patients’ ability to consume a single dose of at least 600 mg of peanut protein, and the secondary end point was consuming a dose of at least 1000 mg of milk, egg, or cashew protein without experiencing moderate to severe allergic symptoms.

The findings demonstrated that a statistically significant higher proportion of patients treated with omalizumab for 16 to 20 weeks had tolerated at least 600 mg of peanut protein without moderate to severe allergic symptoms or reactions compared with those treated with placebo (68% to 5%, respectively). According to the investigators, 600 mg of peanut protein is equivalent to half a teaspoon of regular peanut butter or approximately 2 and a half peanuts.

Further, there was also a significantly higher proportion of patients treated with omalizumab who could tolerate at least 1000 mg of protein from milk (66% vs 11%), egg (67% vs 0%), or cashew (42% vs 3%) without experiencing moderate to severe allergic symptoms, unlike those who received placebo. The investigators emphasize that although the patients treated with omalizumab were able to tolerate the amounts of food, treatment with omalizumab should still be used in addition to the continued avoidance food allergens.

“As more and more people are affected by food allergies, the need for a new approach to help prevent serious and often life-threatening allergic reactions and emergencies is critical,” said Sung Poblete, RN, PhD, CEO of Food Allergy Research and Education, in the press release. “As someone with food allergies, I know firsthand the significant impact they can have on people and their loved ones, and I share in the community’s excitement for this approval.”

According to the study authors, the observed safety profile of omalizumab was consistent with its previously known safety profile across its other indications and prior clinical trials. The most common adverse events reported by patients in the omalizumab arm (≥3%) were injection site reactions (15.5%) and fever (6.4%).

“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,” said Kenneth Mendez, president and CEO of the Asthma and Allergy Foundation of America, in the press release. “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.”


Roche. FDA approves Xolair as first and only medicine for children and adults with one or more food allergies. News release. February 16, 2024. Accessed February 16, 2024. Email.

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