Novartis Announces NMPA Approval of New Indication for Xolair® (Omalizumab) Prefilled Syringe for At-Home Use in Chronic Spontaneous Urticaria

On June 21, Novartis China announced that its innovative biologic Xolair® (omalizumab) prefilled syringe/home-use formulation has been approved by the National Medical Products Administration (NMPA) for a new indication to treat adult and adolescent (12 years and older) patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite treatment with H1 antihistamines. This approval means that CSU patients can now self-administer omalizumab at home, providing a convenient and efficient way to control urticaria symptoms.

Omalizumab is a humanized monoclonal antibody against IgE (immunoglobulin E) that works by specifically binding to free IgE in the serum and blocking its inflammatory pathways. Numerous studies have confirmed the significant benefits of omalizumab in the treatment of chronic spontaneous urticaria.

Since its overseas launch in 2003, Xolair® (Omalizumab) has been approved for the treatment of allergic asthma and chronic spontaneous urticaria in more than 90 countries and regions, including the European Union. In China, Omalizumab was approved in 2017 and 2018 for the treatment of moderate to severe allergic asthma in adults and children aged 6 years and above. In April 2022, Omalizumab was approved for the treatment of adult and adolescent (12 years and above) patients with chronic spontaneous urticaria who continue to experience symptoms despite treatment with H1 antihistamines.

In August 2022, the Omalizumab Prefilled Syringe/Home Use Formulation was approved by the National Medical Products Administration for use in children, adolescents, and adult patients aged 6 years and above with moderate to severe persistent allergic asthma whose symptoms are not effectively controlled after treatment with inhaled corticosteroids and long-acting inhaled β2-adrenergic receptor agonists. It was commercially launched in April 2023.

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