Novartis Advances Remibrutinib for Chronic Spontaneous Urticaria with Promising Long-term Data

1. Positive Phase III Results: Novartis has announced positive results from the REMIX-1 and REMIX-2 Phase III studies, demonstrating the efficacy and safety of remibrutinib in treating chronic spontaneous urticaria (CSU).
2. Long-term Data: The 52-week data from the studies show sustained symptom improvement, with almost half of the patients achieving complete freedom from itch and hives by week 52.
3. Favorable Safety Profile: Remibrutinib was well-tolerated, with adverse events, serious adverse events, and treatment discontinuations similar to the placebo group.
4. Global Filings Planned: Novartis plans to seek global health authority approvals for remibrutinib in CSU starting in the second half of 2024.
5. Extension Study: An extension study is underway to collect long-term efficacy, safety, and tolerability data on remibrutinib in patients with CSU.