Drug Topics February 20, 2024
The approval was based on positive data from a phase 3 trial that showed patients treated with omalizumab were significantly more likely to tolerate peanut, milk, egg, or cashew protein without moderate to severe allergic symptoms.
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...
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