Novartis reports REMIX-1 and REMIX-2 studies met endpoints at Week 12

Novartis announced new “positive” data from the Phase III REMIX-1 and REMIX-2 studies investigating remibrutinib – a highly selective, oral Bruton’s tyrosine kinase inhibitor – in people with chronic spontaneous urticaria, or CSU, whose symptoms are inadequately controlled by H1-antihistamines. In the studies, remibrutinib met all primary and secondary endpoints at Week 12. Remibrutinib demonstrated superiority in change from baseline vs placebo in weekly urticaria activity, itch and hives at Week 12. Significantly more patients achieved well-controlled disease 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 121. Data are being presented at the 2023 American College of Allergy, Asthma and Immunology Scientific Meeting in Anaheim, California, November 9-13.