Novartis remibrutinib Phase III trials met their primary endpoints and showed rapid symptom control in chronic spontaneous urticaria

This medication has not been approved by the FDA yet, but is very promising. There are injectable medications that are available today that are very helpful, but we need new oral, easy to use medications for some of our patients suffering from severe cases of chronic urticaria (hives).

Highlights:

  • The Phase III REMIX-1 and REMIX-2 studies met all primary and secondary endpoints, showing rapid, clinically meaningful improvements across urticaria disease activity scores1
  • Patients on remibrutinib saw rapid improvement as early as 2 weeks after treatment initiation1
  • Remibrutinib, a highly selective oral BTK inhibitor, was well-tolerated and demonstrated a favorable safety profile, including balanced liver function tests in active and placebo arms across both studies1
  • Final (52 weeks) readout and submission in 2024; full data will be presented at upcoming medical meetings
  • If approved, remibrutinib has the potential to become the first of a new class of chronic spontaneous urticaria (CSU) treatment in a decade, offering a simple and effective option for the 60% of patients uncontrolled by H1-antihistamines2

https://www.novartis.com/news/media-releases/novartis-remibrutinib-phase-iii-trials-met-their-primary-endpoints-and-showed-rapid-symptom-control-chronic-spontaneous-urticaria