FDA: Omalizumab Recieves Priority Review Designation for Allergic Reactions


An FDA-approval of Omalizumab would help reduce allergic reactions among 17 million people in the United States who have confirmed food allergies.

The FDA has granted Priority Review designation to Genentech’s omalizumab (Xolair) for the reduction of allergic reactions including anaphylaxis, that can occur with an accidental exposure to 1 or more foods in adult and pediatric patients aged 1 year and older with food allergy.1

Patients taking omalizumab would still need to avoid foods they are allergic to, should the monoclonal antibody be approved for this indication. According to Genentech, the FDA is expected to make an approval decision in the first quarter of 2024.2

Genentech states that 17 million people in the United States have confirmed food allergies. Over 40% of children and more than half of adults with these allergies have experienced a severe reaction at least once.1

The acceptance is based on positive results from the phase 3 OUtMATCH study (NCT03881696), which is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).1,2

The study is a 3-stage, multicenter, randomized, double-blind, and placebo-controlled study, in which only stage 1 has been completed.2

The study’s first stage was designed to assess the efficacy of omalizumab in an increasing amount of food it takes to cause an allergic reaction. Children and adolescents aged 1 to 17 years were enrolled in the study, along with adults aged 18 to 55 years.2

The study’s independent Data and Safety Monitoring Board (DSMB) found that of the 165 initial children and adolescents who received omalizumab injections could consume higher doses of peanut, egg, milk, and cashew without allergic reactions, compared participants that received placebo injections.2

If approved by the FDA, omalizumab would be the first medicine to reduce allergic reactions to multiple foods after an accidental exposure.1

Currently, omalizumab is approved to treat moderate to severe persistent allergic asthma, chronic spontaneous urticaria, and chronic rhinosinusitis with nasal polyps. In the phase 3 trial for reduction of allergic reaction because of an accidental exposure, investigators noted that safety findings were similar with the known benefit-risk profile across the already FDA-approved indications.1

According to the release, Genentech and Norvartis Pharmaceuticals Corporation work together to develop and co-promote omalizumab in the United States.1

This article originally appeared in Contemporary Pediatrics.

  1. FDA grants priority review to Xolair (omalizumab) for children and adults with food allergies based on positive National Institutes of health phase III study results. Genentech. News release. December 19, 2023. Accessed December 19, 2023. https://www.gene.com/media/press-releases/15016/2023-12-19/fda-grants-priority-review-to-xolair-oma
  2. Antibody reduces allergic reactions to multiple foods in NIH trial. National Institutes of Health. News release. December 19, 2023. Accessed December 19, 2023. https://www.nih.gov/news-events/news-releases/antibody-reduces-allergic-reactions-multiple-foods-nih-trial
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