▎WuXiEdited by Kant Content Team

Recently, Roche announced that the U.S. FDA has approved its monoclonal antibody Xolair (omalizumab) for reducing IgE-mediated allergic reactions to accidental exposure to one or more foods in adults and children aged 1 year and older, including anaphylaxis.According to the press release, Xolair is the first approved drug for treating children and adults with one or more food allergies.

The approval by the U.S. FDA is primarily based on positive data from the Phase 3 OUTMATCH clinical trial, which evaluated the efficacy and safety of Xolair in patients aged 1 to 55 who are allergic 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 statistically significant higher proportion of patients treated with Xolair tolerated at least 1000 mg of milk protein (66% vs 11%; p<0.0001), egg (67% vs 0%; p<0.0001), or cashew (42% vs 3%; p<0.0001) without moderate to severe allergic symptoms.

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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