Novartis wins FDA approval of BTK inhibitor remibrutinib for urticaria

Novartis (NYSE:NVS) has received FDA approval for Rhapsido® (remibrutinib), marking a significant breakthrough as the first oral Bruton's tyrosine kinase inhibitor (BTKi) treatment for chronic spontaneous urticaria (CSU) in adults who remain symptomatic despite antihistamine treatment.

The approval is supported by Phase III REMIX-1 and REMIX-2 clinical trials, where Rhapsido demonstrated superior efficacy in reducing itch and hives as early as Week 2, with about one-third of patients achieving complete symptom relief by Week 12. The twice-daily oral medication requires no lab monitoring and offers a new treatment approach for the 1.7 million Americans living with CSU.

The drug works by targeting BTK to inhibit histamine release and proinflammatory mediators. Novartis has submitted regulatory applications for Rhapsido across multiple countries, including the EU, Japan, and China, with priority review granted in China.

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