Novartis rounds off remibrutinib data package ahead of CSU filing

At last month’s European Academy of Dermatology and Venereology (EADV) congress in Amsterdam, Novartis (NOVN: VX) presented new early and long-term Phase III data for remibrutinib in chronic spontaneous urticaria (CSU).

The highly-selective oral Bruton’s tyrosine kinase inhibitor has previously shown superior efficacy versus placebo and favorable safety in the 24-week double-blind period of the Phase III REMIX-1 /-2 studies. Now, the Swiss pharma giant has presented the 52-week data from the trials.

Results show significant improvement, observed as early as week one, in the proportion of patients achieving weekly urticaria activity score (UAS7)≤6, with remibrutinib versus placebo.