Robert Wood, MD: Impact of Omalizumab Approval on Management of Pediatric Food Allergy

The February 16, 2024 approval of omalizumab (Xolair) for represents a significant milestone for the allergy and immunology communities as the US Food and Drug Administration’s first approval for helping to reduce allergic reactions to multiple foods after accidental exposure.¹

Specifically approved for immunoglobulin E-mediated food allergy in certain adults and children 1 year or older for the reduction of allergic reactions (Type I), including reducing the risk of anaphylaxis, that may occur with accidental exposure to one or more foods, the approval was awarded to Genentech who works in partnership with Novartis Pharmaceuticals Corporation to co-promote the agent. It is the first FDA-approved medication to reduce allergic reactions to more than one type of food after accidental exposure.^1,2

"This newly approved use for Xolair will provide a treatment option to reduce the risk of harmful allergic reactions among certain patients with IgE-mediated food allergies," said Kelly Stone, MD, PhD, associate director of the Division of Pulmonology, Allergy, and Critical Care in the FDA's Center for Drug Evaluation and Research.¹ "While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs."

The approval comes just 59 days after Genentech announced the FDA had accepted the company’s supplemental Biologics License Application for priority review in management of food allergies among pediatric and adult patients. Omalizumab has received multiple previous indications from the FDA dating back to its initial approval in 2003 for the treatment of moderate to severe persistent allergic asthma in certain patients.^1,2,3

According to a release from Novartis, the approval is based on data from the phase 3 OUtMATCH trial. Sponsored by the National Institutes of Health, the trial, which enrolled patients food allergy as young as 1 year, demonstrated use of omalizumab was associated with a significantly greater proportion of food allergy patients being able to tolerate small amounts of peanut, milk, egg and cashew without an allergic reaction, compared to placebo. A full presentation of data from the trial are scheduled to be presented on Sunday, February 25, 2024 by Wood at the 2024 American Academy of Allergy, Asthma, and Immunology Annual Meeting.^1,2,3

As the FDA notes in their announcement, omalizumab is intended for repeated use to reduce the risk of allergic reactions and is not approved for the immediate emergency treatment of allergic reactions, including anaphylaxis. Additionally, omalizumab will come with a boxed warning for anaphylaxis, which can be life threatening, based on pre-marketing and post-marketing reports of anaphylaxis occurring post-administration.¹

With an interest in learning more about how this approval impacts the treatment landscape for pediatric and adolescent patients with food allergy, as well as their adult counterparts, check out our post-approval interview with Wood found below.

Relevant disclosures for Wood include Immune, Genetic, Novartis, Regeneron, and others.

References:

1. _{^{Office of the Commissioner. FDA approves first medication to help reduce allergic reactions to multiple foods after accidental exposure. U.S. Food and Drug Administration. February 16, 2024. Accessed February 22, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-medication-help-reduce-allergic-reactions-multiple-foods-after-accidental.}}
2. _{^{Novartis United States of America. FDA approves Xolair® (omalizumab) as first and only medicine for children and adults with one or more food allergies. Novartis United States of America. February 16, 2024. Accessed February 22, 2024. https://www.novartis.com/us-en/news/media-releases/fda-approves-xolair-omalizumab-first-and-only-medicine-children-and-adults-one-or-more-food-allergies.}}
3. _{^{Genentech. 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: Press Releases | Tuesday, Dec 19, 2023. December 19, 2024. Accessed February 22, 2024. https://www.gene.com/media/press-releases/15016/2023-12-19/fda-grants-priority-review-to-xolair-oma.}}