It can be a scary world for parents and children with moderate to severe allergies, especially if the allergy is to a common food ingredient like wheat, milk or peanut butter. There is currently no cure for food allergy, with an EpiPen as the most common treatment for immediate accidental exposure.
Last week, though, the FDA approved the first-ever medication to treat allergic reactions after accidental exposure.
Xolair, or omalizumab, is an injection for immunoglobulin E-mediated food allergy in adults and children 1 year or older for the reduction of allergic reactions (Type I), including the risk of anaphylaxis, that may occur with accidental exposure to one or more foods.
The medication 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.
“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,” said Kelly Stone, M.D., associate director in the FDA’s Center for Drug Evaluation and Research. “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.”
Xolair’s safety and efficacy was established in an NIH-backed multi-center, double-blind, placebo study of 168 pediatric and adult subjects who were allergic to peanut and at least two other foods, including milk, egg, wheat, cashew, hazelnut or walnut. Researchers 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 of peanut protein (600 mg, equivalent to 2.5 peanuts) without moderate to severe allergic symptoms—including skin, respiratory or gastrointestinal symptoms—at the end of the treatment course.
According to the trial results, of those who received Xolair, 68% were able to eat the single dose of peanut protein without moderate to severe allergic symptoms, compared with 6% who received the placebo. Of note, however, 17% of subjects who received Xolair had no significant change in the amount of peanut protein tolerated (could not tolerate 100 mg or more of peanut protein). As a result, continuation of strict allergen avoidance is still necessary, despite treatment with Xolair.
Since Xolair is intended to treat multiple food allergies, the second endpoint of the trial was the percentage of subjects 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 treatment course.
According to the trial results, for cashew-allergic patients, 42% who received Xolair achieved this endpoint, compared with 3% who received the placebo. For milk, 66% of those given Xolair were able to tolerate a single dose of the dairy product, compared with 11% who received the placebo. Lastly, for egg-allergic patients, 67% achieved the endpoint, compared to 0% of patients who received the placebo.
Ultimately, the trial data shows Xolair is most effective for peanut and egg allergies, but can provide life-saving treatment for many other allergies as well.
The most severe side effect of Xolair is anaphylaxis, which was shown to occur after the first dose as well as beyond one year of beginning treatment. Thus, the FDA says Xolair should only be started in a healthcare setting equipped to manage anaphylaxis. But, for selected patients who tolerate initial Xolair treatments in a healthcare setting without anaphylaxis, self-administration may be appropriate.
In the U.S., Xolair is manufactured by Novartis Pharmaceuticals and Genentech.