• Significant improvements as early as Week 1, favorable safety profile and no liver safety concerns in REMIX 1 & 2 studies of highly selective, oral BTKi¹
  
  
• Rhapsido recommended in 2026 International Urticaria Guideline for all patients who remain symptomatic after H1-antihistamine treatment²
  
  
• CSU affects nearly 4 million people in Europe; more than 50% continue to experience debilitating symptoms after conventional antihistamine therapy^3-5
  

Novartis announced that the European Commission (EC) approved Rhapsido^® (remibrutinib) for chronic spontaneous urticaria (CSU) in adult patients with inadequate response to H1-antihistamine treatment. Rhapsido is the first oral targeted treatment approved for CSU, offering a unique approach to CSU treatment in a pill taken twice daily without any lab monitoring required.

“CSU is a serious disease that causes debilitating symptoms, like itch and swelling, with unpredictable flares that greatly impact patients' emotional wellbeing, sleep, and productivity,” says Prof. Dr med. Martin Metz, Deputy Director, Institute of Allergology, Charité Universitätsmedizin Berlin, Germany. “The approval of Rhapsido marks a major step forward, offering fast relief by blocking a key immune pathway, which may help a broad range of patients experience significant control of their disease.”

Rhapsido received a positive opinion in February 2026 from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and is included in the 2026 International Guideline for the Definition, Classification, Diagnosis and Management of Urticaria².

“Today’s approval represents an important advance for CSU patients, offering new hope for faster relief and better day to day disease control. Rhapsido is being developed for multiple immune-mediated conditions in addition to CSU— such as chronic inducible urticaria, food allergy, hidradenitis suppurativa—highlighting the broad potential of a targeted oral BTK pathway approach,” said Patrick Horber, M.D., President, International, Novartis.