Novartis Receives FDA Approval for Remibrutinib in Chronic Spontaneous Urticaria

Novartis today announced that the FDA has approved remibrutinib for the treatment of adults and adolescents 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite antihistamine treatment. This approval makes remibrutinib the first oral BTK inhibitor approved for CSU. The approval was based on results from the Phase 3 REMIX-1 and REMIX-2 trials, which demonstrated statistically significant improvements in UAS7 scores compared to placebo. Remibrutinib is an oral, highly selective BTK inhibitor that targets the underlying pathophysiology of CSU by inhibiting mast cell and basophil activation. This approval provides patients with CSU a new convenient oral treatment option.