Omalizumab injection (Xolair) has been FDA approved for immunoglobulin E-mediated food allergy in adults and children aged 1 year or older for the reduction of type 1 allergic reactions—including the risk of anaphylaxis—that may result from accidental exposure to certain foods, the federal agency announced in a release.1
The approval is based on positive data from the OUtMATCH study (NCT03881696), a phase 3, multi-center, randomized, double-blind, placebo-controlled trial evaluating omalizumab in patients aged 1 to 55 years who are allergic to peanuts and at least 2 other food allergens, including milk, egg, wheat, cashew, hazelnut and walnut. The study was sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID).
Key Takeaways
- Omalizumab injection (Xolair) has received FDA approval for the treatment of immunoglobulin E (IgE)-mediated food allergy in both adults and children aged 1 year or older. The approval is specifically for reducing type 1 allergic reactions, including the risk of anaphylaxis, resulting from accidental exposure to certain foods.
- The FDA approval is based on positive results from the OUtMATCH study, a phase 3, multi-center, randomized, double-blind, placebo-controlled trial. The study evaluated omalizumab in patients aged 1 to 55 years with allergies to peanuts and at least two other food allergens. Omalizumab demonstrated effectiveness in reducing allergic symptoms during food challenges.
- Omalizumab is the first FDA-approved medication designed to reduce allergic reactions to more than one type of food allergen. While it does not cure food allergies, its repeated use can help minimize the health impact if accidental exposure occurs. This approval provides a new treatment option for patients dealing with IgE-mediated food allergies, addressing a significant burden in managing such conditions.
The study cohort included 168 participants who were unable to tolerate up to 100 mg of peanut protein, and up to 300 mg each of milk, egg and cashew protein. The participants received 16 to 20 weeks of treatment with either omalizumab or placebo. They then were asked to complete 4 food challenges in which they gradually received increasing amounts of foods they are allergic to. This was done to assess their ability to consume 1 dose of at least 600 mg of peanut protein and 1 dose of at least 1,000 mg of milk, egg or cashew protein without experiencing moderate to severe allergic symptoms.
The study found that patients treated with omalizumab were significantly more likely to tolerate at least 600 mg of peanut protein without moderate to severe allergic symptoms. Patients treated with omalizumab were also significantly more likely to tolerate at least 1,000 mg of milk, egg, or cashew protein without moderate to severe allergic symptoms. Additionally, omalizumab was well tolerated, with the most common adverse events being injection site reaction and fever.
“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,” Kelly Stone, MD, PhD, associate director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research, said in a release.1 “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.”
READ MORE: Cedar Pollen-specific IgE Titers May Be Useful in Pollen Allergy Screening
Omalizumab received initial approval in 2003 to treat moderate to severe persistent allergic asthma in certain patient populations; it is also indicated to treat chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps.
For individuals with food allergies, exposure to certain foods can lead to allergic reactions such as anaphylaxis, which can be life threatening. There is no cure for food allergies; the disease must be managed through avoidance of allergic foods and administration of epinephrine after accidental exposure—a significant burden for the estimated 6% of individuals in the United States living with food allergies, as of 2021.
Palforzia (peanut [arachis hypogaea] allergen powder-dnfp) was approved by the FDA in January 2020 to manage allergic reactions to peanut exposure in children aged 4 to 17 years.2 Omalizumab is the first approved medication to reduce allergic reactions to more than one type of food allergen.
People taking omalizumab should still continue avoiding foods that they are allergic to, as it is intended for repeated use to reduce risk. The injection should not be used to treat emergency allergic reactions, including anaphylaxis.
“Xolair 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,” Levi Garraway, MD, PhD, Genentech's chief medical officer and head of Global Product Development, said in a release.3 “[The] approval builds on 20 years of patient experience and an established efficacy and safety profile since Xolair was first approved in allergic asthma. We look forward to bringing this treatment to the food allergy community who have long awaited an advancement.”
READ MORE: Allergy Resource Center
References
