Xolair® is the commercial brand name of Omalizumab for Injection, a humanized monoclonal antibody developed by Novartis. It selectively binds to free IgE in blood, lowers serum IgE concentration and down-regulates FcεRI receptors on mast cells and basophils, thereby reducing allergic inflammatory activation.
Main Indications
Treatment of moderate to severe persistent allergic asthma in adult patients with positive allergen tests and insufficient symptom control with inhaled corticosteroids; also indicated for chronic spontaneous urticaria in patients inadequately responding to H1 antihistamines.
Clinical Research
Global phase III trials demonstrated that omalizumab reduces asthma exacerbations, improves lung function and asthma-related quality of life in allergic asthma patients;
Multiple studies confirmed its efficacy in chronic spontaneous urticaria by lowering itch severity and reducing urticaria flare frequency;
Long-term extension studies showed sustained safety and efficacy profile during prolonged treatment.
Common Side Effects
Severe but important risks: Anaphylaxis and severe systemic hypersensitivity reactions, elevated risk of parasitic infection;
Common mild adverse reactions: Injection site pain and swelling, headache, upper respiratory tract infection, arthralgia and fatigue.
Approval Status in China
Original drug Xolair® (Omalizumab for Injection, specification:150mg per vial) was officially approved for marketing in China in 2018. It is currently a prescription anti-IgE monoclonal antibody.
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