The US Food and Drug Administration (FDA) approved Xolair (omalizumab) injection for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with immunoglobulin E (IgE)-mediated food allergy. 

Xolair was originally approved in 2003 for the treatment of moderate to severe persistent allergic asthma in certain patients. Xolair is also approved to treat chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps in certain patients.

The approval makes Xolair the first and only FDA-approved medicine to reduce allergic reactions in people with one or more food allergies. Xolair is available and can now be prescribed for appropriate patients with IgE-mediated food allergy in the US. 

“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,” says 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, in a release. “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.”  

The FDA approval was based on positive data from the phase III OUtMATCH study, which evaluated Xolair in patients aged 1 to 55 years allergic to peanuts and at least two other food allergens, including milk, egg, wheat, cashew, hazelnut, and walnut. 

Researchers randomly gave subjects either Xolair or placebo treatment for 16 to 20 weeks. The primary measure of Xolair’s efficacy was the percentage of subjects who were able to eat a single dose (600 milligrams or greater) of peanut protein (equivalent to 2.5 peanuts) without moderate to severe allergic symptoms, such as moderate to severe skin, respiratory or gastrointestinal symptoms, at the end of the 16- to 20-week treatment course. 

Of those who received Xolair, 68% (75 of 110 subjects) were able to eat the single dose of peanut protein without moderate to severe allergic symptoms (eg, whole body hives, persistent coughing, vomiting), compared to 6% (3 of 55 subjects) who received placebo; these results are statistically significant and clinically meaningful for subjects with food allergy. Of note, however, 17% of subjects receiving Xolair had no significant change in the amount of peanut protein tolerated (could not tolerate 100 milligrams or more of peanut protein). As a result, continuation of strict allergen avoidance is still necessary, despite treatment with Xolair.

The key secondary measures of efficacy were the percentage of subjects who were able to consume a single dose (1,000 milligrams or greater) of cashew, milk, or egg protein without moderate to severe allergic symptoms at the end of the 16- to 20-week treatment course. For cashew, 42% (27 of 64 subjects) who received Xolair achieved this endpoint compared to 3% (1 of 30 subjects) who received placebo. For milk, 66% (25 of 38 subjects) who received Xolair achieved this endpoint, compared to 11% (2 of 19) who received placebo. For egg, 67% (31 of 46 subjects) who received Xolair achieved this endpoint, compared to 0% of the 19 who received placebo. As a result, Xolair treatment is approved for certain patients with one or more IgE-mediated food allergies.

The most common side effects of Xolair observed included injection site reactions and fever. 

Detailed results from the study will be featured in a late-breaking symposium at the 2024 American Academy of Allergy, Asthma, & Immunology Annual Meeting on Sunday, Feb 25.

Xolair comes with a boxed warning for anaphylaxis based on pre-marketing and post-marketing reports of anaphylaxis that occurred after Xolair administration. Anaphylaxis has occurred after the first dose of Xolair but also has occurred beyond one year after beginning treatment. Xolair should only be started in a healthcare setting equipped to manage anaphylaxis. 

For selected patients who tolerate initial Xolair treatments in a healthcare setting without anaphylaxis, self-administration (or administration by a caregiver) may be appropriate and should be discussed with a healthcare provider. 

People taking Xolair for food allergies should continue to avoid all foods they are allergic to. Xolair should not be used for the emergency treatment of any allergic reactions, including anaphylaxis. 

Xolair received Priority Review and Breakthrough Therapy designations for this indication. The FDA granted the approval of Xolair to Genentech. 

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