Core Insights - Roche announced positive data from Stage 2 and Stage 3 of the NIH-sponsored phase III OUtMATCH study, supporting Xolair® (omalizumab) for treating food allergies [1][2] - Xolair demonstrated superior efficacy and fewer side effects compared to multi-allergen oral immunotherapy (OIT) in a head-to-head trial [4][6] - The findings provide healthcare providers with valuable data to address the needs of food allergy patients [3] Study Results - In Stage 2, 36% of patients treated with Xolair could tolerate at least 2,000 mg of peanut protein, compared to 19% in the OIT group (odds ratio=2.6, P=0.031) [4][6] - Serious adverse events (AEs) were significantly higher in the OIT group (30.5% vs. 0% for Xolair), with AEs leading to treatment discontinuation at 22% for OIT compared to 0% for Xolair [6] - Stage 3 preliminary results indicated that many patients could introduce allergenic foods into their diets after stopping Xolair, with success rates varying by allergen type [9] FDA Approval and Market Position - Xolair is the first and only FDA-approved medication to reduce allergic reactions in individuals with one or more food allergies, including anaphylaxis [10][16] - The FDA approved Xolair for food allergies on February 16, 2024, based on data from the OUtMATCH study [10][14] - The study is part of a broader effort to address the rising prevalence of food allergies, affecting approximately 3.4 million children and 13.6 million adults in the US [12][13] Company Background - Roche, founded in 1896, is a leading biotechnology company focused on developing innovative medicines and diagnostics [19][20] - The OUtMATCH study is sponsored by the NIH and conducted by the NIAID-funded Consortium for Food Allergy Research at multiple clinical sites [15]
Phase III study shows Xolair may be more effective with fewer side effects than oral immunotherapy for the treatment of food allergies