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FDA Grants Priority Review for Roche’s Xolair® (omalizumab) for Food Allergies

Dec 19, 2023

Roche announced that the FDA has accepted for priority review its Biologics License Application (BLA) for Xolair® (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with an accidental exposure to one or more foods.  The BLA relates to treatment of adult and paediatric patients aged one year and older with food allergy.  The FDA expects to make a decision on approval in Q1 2024.  In the US Genentech (Roche) and Novartis  co-promote Xolair®.