▎WuXiEdited by Kant Content Team

Recently, Roche announced that the Phase 1 data of its pivotal Phase 3 clinical trial OUtMATCH has been"The New England Journal of Medicine"（NEJM) was published.The research results show that,The study showed that the use of Xolair (omalizumab) increased tolerance to peanuts, milk, eggs, wheat, and several nuts (including cashews, hazelnuts, and walnuts) in children over the age of 1 with multiple food allergies, which would otherwise have caused moderate to severe allergic reactions in these patients.

OUtMATCH Phase 3 Clinical Study Evaluates the Efficacy and Safety of Xolair in Patients Aged 1 to 55 with Allergies to Peanuts and at Least Two Other Allergens (Including Milk, Eggs, Wheat, Cashews, Hazelnuts, and Walnuts). The study found,In the patient group receiving Xolair treatment for 16 to 20 weeks, 68% of patients were able to tolerate at least 600 milligrams of peanut protein without experiencing moderate to severe allergic symptoms. This proportion is significantly statistically different (p<0.0001) compared to 5% in the patient group receiving placebo treatment.

Moreover, compared with the placebo group, a significantly higher proportion of patients treated with Xolair tolerated at least 1000 mg of milk protein (66% vs 11%; p<0.0001), eggs (67% vs 0%; p<0.0001), or cashews (42% vs 3%; p<0.0001) without moderate to severe allergic symptoms. Detailed results are shown in the table below:

▲Percentage of patients who successfully consumed seven predetermined threshold doses of food (Image source: Reference [1])

In the study, the incidence of adverse reactions was similar between Xolair and placebo. The most common adverse reaction in children and adolescents receiving Xolair was injection site reactions (9%).

According to the positive data from OUtMATCH, the U.S. FDA has already done so on February 16, 2024.ApprovalXolair is used to reduce allergic reactions, including anaphylaxis, that may occur in adults and children over 1 year old with IgE-mediated food allergies due to accidental exposure to one or more foods.According to the press release, Xolair is the first approved drug for treating children and adults with one or more food allergies.

Xolair, jointly developed by Genentech, a subsidiary of Roche, and Novartis, is an antibody that targets and blocks IgE. By reducing free IgE, downregulating high-affinity IgE receptors, and limiting mast cell degranulation, Xolair minimizes mediator release throughout the entire allergic inflammatory cascade.In August 2018, the FDA granted Xolair Breakthrough Therapy Designation for the prevention of severe allergic reactions caused by accidental exposure in individuals allergic to one or more foods. Xolair is currently approved by the FDA for the treatment of moderate to severe persistent allergic asthma, chronic spontaneous urticaria (CSU), and chronic rhinosinusitis with nasal polyps (CRSwNP).

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References:

[1] New England Journal of Medicine publishes Phase III data showing Xolair significantly reduced allergic reactions across multiple foods in people with food allergies. Retrieved February 26, 2024, from https://www.globenewswire.com/news-release/2024/02/25/2834763/0/en/New-England-Journal-of-Medicine-publishes-Phase-III-data-showing-Xolair-significantly-reduced-allergic-reactions-across-multiple-foods-in-people-with-food-allergies.html

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