FDA to Review Omalizumab for Patients With Food Allergies

The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for omalizumab for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to 1 or more foods in adults and pediatric patients aged 1 year and older with food allergy.

Omalizumab, an anti-immunoglobulin E (IgE) antibody, is marketed under the brand name Xolair for the treatment of asthma, chronic rhinosinusitis with nasal polyps and chronic spontaneous urticaria. 

The BLA is supported by data from the phase 3, double-blind, placebo-controlled OUtMATCH trial (ClinicalTrials.gov Identifier: NCT03881696), which evaluated the safety and efficacy of omalizumab in patients 1 to 55 years of age who are allergic to peanuts and at least 2 other common foods. The multi-stage study is sponsored and funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. In the first stage, patients were randomly assigned to receive omalizumab injections (either every 2 weeks or every 4 weeks) or placebo for 16 to 20 weeks. 

Data from the first 165 participants aged 1 to 17 years were examined at a pre-planned interim analysis by an independent data and safety monitoring board (DSMB). Findings showed that compared with placebo, omalizumab significantly increased the amount of peanut (primary endpoint), milk, egg, and cashew (key secondary endpoints) participants could consume without an allergic reaction. Based on these results, the DSMB recommended halting enrollment into the first stage of the trial.

“Despite the significant and growing health burden from food allergies, treatment advances have been limited,” said Levi Garraway, MD, PhD, Genentech’s chief medical officer and head of Global Product Development. “We are proud to partner with the National Institutes of Health and leading research institutions on this groundbreaking study. The FDA’s Priority Review designation acknowledges the unmet need for these patients, and we hope to make Xolair available to as many people as possible living with food allergies in the US.”

The FDA’s decision on the application is expected in the first quarter of 2024. If approved, omalizumab would be the first drug approved to reduce allergic reactions to multiple foods following accidental exposure.