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# Priority Review for Xolair Food Allergy sBLA
- URL: https://www.fdaweb.com/priority-review-for-xolair-food-allergy-sbla/
- Published: 2024-01-22T12:00:00.000Z
- Updated: 2026-09-14T14:20:52.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5156180

FDA has accepted for priority review a Genentech supplemental BLA for Xolair (omalizumab) for reducing allergic reactions, including anaphylaxis, that may occur with an accidental exposure to one or more foods in adult and pediatric patients with a food allergy. The submission is based on the “positive” data from the Phase3 OUtMATCH study evaluating Xolair in patients allergic to peanuts and at least two other common foods, according to the company. A user fee review action is expected by 3/31, and, if approved, Xolair would be the first therapy to reduce allergic reactions to multiple foods following an accidental exposure. Despite its effectiveness, those taking Xolair would still need to avoid foods to which they are allergic (commonly referred to as ‘food avoidance’), the company says.