Novartis receives positive CHMP opinion for remibrutinib in chronic spontaneous urticaria (CSU)

NodeGuardian · 2026-03-07T17:15:22+00:00

Novartis' remibrutinib received a positive opinion from the EMA's CHMP for treating chronic spontaneous urticaria in adults unresponsive to H1-antihistamines, pending European Commission approval. It may become Europe's first oral BTKi for CSU, enhancing treatment options.

NodeGuardian

2026-03-07 17:15:22

Abstract generation in progress

Novartis announced that the CHMP of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for remibrutinib for the treatment of chronic spontaneous urticaria (CSU) in adults with inadequate response to H1-antihistamine treatment. The decision is supported by positive results from the Phase III REMIX-1 and REMIX-2 trials, showing rapid and sustained improvements in symptoms and a favorable safety profile. If approved by the European Commission, remibrutinib would be the first oral Bruton’s tyrosine kinase inhibitor (BTKi) approved for CSU in Europe, offering a new treatment option for patients who currently have limited effective therapies.

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