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# Novartis Reports Positive Data on Remibrutinib
- URL: https://www.fdaweb.com/novartis-reports-positive-data-on-remibrutinib/
- Published: 2023-08-09T12:00:00.000Z
- Updated: 2026-09-14T18:49:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155056

Novartis says top-line data from two Phase 3 studies evaluating remibrutinib 25 mg in patients with chronic spontaneous urticaria (CSU) met their primary endpoint of absolute change from baseline in weekly urticaria activity score (UAS7) at Week 12, “demonstrating clinically meaningful and statistically significant improvements in disease activity.” Remibrutinib also demonstrated a rapid onset of action as illustrated by the improvement of UAS7 at Week 2 in the REMIX-1 and REMIX-2 studies, it says. The studies will continue until Week 52.

The Bruton’s tyrosine kinase (BTK) inhibitor was studied in patients with chronic spontaneous urticaria (CSU) whose symptoms are inadequately controlled by H1-antihistamines, according to Novartis. CSU refers to chronic hives that last for six weeks or longer, where the underlying cause is internal rather than external exposure to any allergen, it says. H1-antihistamines are the first-line treatment for the condition, and about 60% of patients are inadequately controlled, it adds.

Novartis says it will present the REMIX data at an upcoming medical meeting and intends to file submission to global health authorities starting in 2024.