Novartis Announces Positive Phase 3 Results for Remibrutinib in Chronic Spontaneous Urticaria

Novartis today announced positive results from the Phase 3 REMIX-1 and REMIX-2 trials evaluating remibrutinib in patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite antihistamine treatment. Both trials met their primary endpoints, demonstrating statistically significant improvements in the Urticaria Activity Score over 7 days (UAS7) 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. These results position remibrutinib as a potential new oral treatment option for patients with inadequately controlled CSU.