Novartis data show potential of remibrutinib in urticaria

Swiss pharma giant Novartis (NOVN: VX) has released positive new data from the Phase III REMIX-1 and REMIX-2 studies investigating remibrutinib – a highly selective, oral Bruton’s tyrosine kinase (BTK) inhibitor – in people with chronic spontaneous urticaria (CSU) whose symptoms are inadequately controlled by H1-antihistamines.

In the studies, remibrutinib met all primary and secondary endpoints at Week 12. The drug also demonstrated superiority in change from baseline versus placebo in weekly urticaria activity (UAS7), itch (ISS7) and hives (HSS7) at Week 12.

Significantly, said Novartis, more patients achieved well-controlled disease (UAS7≤6) with remibrutinib vs placebo, as early as Week 2 which was sustained at Week 12, and about one third of patients achieved complete absence of itch and hives at Week 12.