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<p>Remibrutinib (Rhapsido<sup>®</sup>) is an orally administered, selective Bruton’s tyrosine kinase (BTK) inhibitor being developed by Novartis for the treatment of chronic spontaneous urticaria (CSU) as well as other immune-mediated disorders. On 30 September 2025 remibrutinib received its first approval in the USA for treatment of CSU in adult patients who remain symptomatic despite H<sub>1</sub>-antihistamine treatment. It has subsequently been approved for use in the same indication in China and is under regulatory review in the EU and Japan. This article summarises the milestones in the development of remibrutinib leading to this first approval for CSU in adult patients who remain symptomatic despite H<sub>1</sub>-antihistamine treatment.</p>

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Remibrutinib: First Approval

  • 期刊论文

  • 发表日期：

    2026年1月21日

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  • Simon Fung

摘要

Remibrutinib (Rhapsido®) is an orally administered, selective Bruton’s tyrosine kinase (BTK) inhibitor being developed by Novartis for the treatment of chronic spontaneous urticaria (CSU) as well as other immune-mediated disorders. On 30 September 2025 remibrutinib received its first approval in the USA for treatment of CSU in adult patients who remain symptomatic despite H1-antihistamine treatment. It has subsequently been approved for use in the same indication in China and is under regulatory review in the EU and Japan. This article summarises the milestones in the development of remibrutinib leading to this first approval for CSU in adult patients who remain symptomatic despite H1-antihistamine treatment.