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Xolair Approved by FDA as First Treatment for Multiple Food Allergies in Adult, Pediatric Patients


Novartis’ and Roche’s Xolair (omalizumab) is indicated to treat severe allergic reactions after accidental exposure to one or more foods in individuals aged one year and above.

Image credit: bit24 | stock.adobe.com. Food allergy. Allergic food on wooden background.

Image credit: bit24 | stock.adobe.com

The FDA has approved an expanded indication for Novartis’ and Roche’s Xolair (omalizumab) as the first medication indicated to reduce allergic reactions from exposure to one or more food allergens in individuals over 1 year of age with immunoglobulin E (IgE)-mediated food allergy.1

Xolair is a monoclonal antibody that binds to and inhibits IgE, which is involved in the pathophysiology of the allergic inflammation characteristic of asthma.2

Through this mechanism of action, IgE down-regulates the immune response to help gain control over allergy-driven inflammation.

"Many people with food allergies and their loved ones live in constant fear of accidentally coming into contact with the food they are allergic to and the life-threatening allergic reaction that could happen as a result. Today's approval of Xolair represents a paradigm shift in the way food allergies can be managed," Reshema Kemps-Polanco, executive vice president and chief commercial officer, Novartis US, said in a press release. "This approval, which comes 20 years after the first approval for this medicine, shows that we never stop innovating to make a meaningful difference for patients living with immunological conditions."1

The FDA previously granted the supplemental Biologics License Application for Xolair with Priority Review status.3 The FDA granted Xolair with Breakthrough Therapy Designation in August 2018 to prevent severe allergic reactions after accidental exposure to one or more foods in people with allergies. Xolair is also approved to treat moderate to severe persistent allergic asthma, chronic spontaneous urticaria, and chronic rhinosinusitis with nasal polyps.

The regulatory action was based on a positive interim analysis of data by an independent Data and Safety Monitoring Board (DSMB) from the National Institutes of Health-sponsored, pivotal multicenter, randomized, double-blind, placebo-controlled Phase III OUtMATCH trial (NCT03881696). The study analyzed Xolair in patients allergic to peanuts and at least two other common foods. The DSMB analyzed data from the first 165 patients aged 1 to 17 years who participated in the first stage of the trial, which showed the study achieved its primary endpoint and key secondary endpoints.

Compared with placebo, Xolair was found to significantly increase the amount of peanuts—the trial’s primary endpoint—and milk, egg, and cashew—the trial’s key secondary endpoints—that it takes to trigger an allergic reaction in participants with food allergies.

Among those administered Xolair for 16 to 20 weeks, 68% tolerated at least 600 mg of peanut protein without moderate to severe allergic symptoms vs. 5% of individuals administered the placebo. The 600 mg amount of peanut protein translates to approximately two-and-a-half peanuts or a half-teaspoon of peanut butter.

In terms of safety, adverse events were consistent with the previously established benefit-risk profile of Xolair for its approved indications in prior clinical trials.

"The stress of living with food allergies can weigh heavily on people and their families, particularly when navigating events like children's birthday parties, school lunches, and holiday dinners with friends and family," President and CEO of the Asthma and Allergy Foundation of America Kenneth Mendez, said in a press release. "Given the growing prevalence of food allergies, this news offers hope to the many children and adults who may benefit from a new way to help manage their food allergies."1


1. FDA approves Xolair® (omalizumab) as first and only medicine for children and adults with one or more food allergies. Novartis. News release. February 16, 2024. Accessed February 16, 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#:~:text=EAST%20HANOVER%2C%20N.J.%2C%20Feb.,patients%20aged%201%20year%20and

2. Delimpoura V, Bonstantzoglou C, Liu N, Nenna R. Novel therapies for severe asthma in children and adults. Breathe (Sheff). 2018 Mar;14(1):59-62. Accessed February 16, 2024.

3. 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 February 16, 2024. https://www.gene.com/media/press-releases/15016/2023-12-19/fda-grants-priority-review-to-xolair-oma

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