Expanded Use of Xolair to Treat Food Allergies Approved by the FDA

FRIDAY, Feb. 16, 2024 (HealthDay News) -- The U.S. Food and Drug Administration has expanded the use of the asthma drug Xolair (omalizumab) to help prevent anaphylactic reactions.

Xolair is an injected drug and is not meant as a substitute for EpiPens or other anaphylaxis rescue remedies, the agency stressed. Instead, "Xolair is intended for repeated use to reduce the risk of allergic reactions" that may occur with accidental exposure to multiple types of foods, the FDA explained in a news release.

Xolair was first approved in 2003 for the treatment of moderate-to-severe allergic asthma. It has also been approved to treat urticaria, as well as 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 immunoglobulin E-mediated food allergies," Kelly Stone, M.D., said in the news release. She is associate director of the Division of Pulmonology, Allergy, and Critical Care in the FDA 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 effectiveness were tested in a trial of 168 babies, children, and adults. Participants were allergic to peanuts and at least two other foods, including milk, egg, wheat, cashew, hazelnut, or walnut, the FDA said. After receiving Xolair or a placebo for up to five months, "of those who received Xolair, 68 percent [75 of 110 subjects] were able to eat the single dose of peanut protein without moderate-to-severe allergic symptoms [e.g., whole body hives, persistent coughing, vomiting], compared to 6 percent [three of 55 subjects] who received placebo," the FDA said.

The study did not find any lessening of overall peanut allergy in people who received Xolair, however, so "continuation of strict allergen avoidance is still necessary, despite treatment with Xolair," the agency stressed. Similar results were found among people allergic to cashew, milk, or egg. In a minority of patients, anaphylaxis can occur after taking Xolair, so the FDA is including a boxed warning with the drug.

The expanded approval of Xolair was granted to Genentech.

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