Novartis Submits NDA to FDA for Remibrutinib in Chronic Spontaneous Urticaria

Novartis today announced the submission of a New Drug Application (NDA) to the FDA for remibrutinib for the treatment of chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 years and older. The submission is based on positive 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. If approved, remibrutinib would be the first oral BTK inhibitor approved for CSU, providing patients with a new oral treatment option for this chronic skin condition.