Novartis has presented positive results from two phase 3 trials measuring its BTK inhibitor, remibrutinib, against teriflunomide for patients with relapsing multiple sclerosis (RMS). The trials showed that remibrutinib reduced relapse rates to approximately one every 13 years and enabled more than 92% of patients to remain free from disease progression over 24 months.
Remibrutinib did not show any liver safety signals, including any Hy’s Law cases, which have been reported in other late-stage BTK inhibitor programmes.
Heinz Wiendl, Professor of Neurology and Chair of the Department of Neurology and Neurophysiology at the Medical Center, University of Freiburg, said: “As treatment goals in MS continue to evolve beyond relapse control alone, these efficacy findings, together with the favourable safety profile, suggest remibrutinib has the potential to deliver a meaningful, differentiated treatment option for people living with RMS.”
Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system characterised by myelin destruction and axonal damage in the brain, optic nerves and spinal cord. MS, which affects nearly three million people worldwide, can be divided into three main types: non-active secondary progressive (SPMS), primary progressive (PPMS), and relapsing MS (RMS).
RMS is the most common form and includes clinically isolated syndrome (CIS), relapsing-remitting (RRMS) and active SPMS. The various forms of MS are differentiated by how the disease presents and progresses, including whether patients experience relapses, worsening disability over time or a combination of both.
Shreeram Aradhye, President, Development and Chief Medical Officer, Novartis, commented: “The…results reinforce our confidence in remibrutinib and its potential to expand treatment choice for people living with RMS. By combining high efficacy with a favourable safety profile through a selective mechanism, remibrutinib has the potential to support long-term disease management without chronic B-cell depletion and to redefine what may be possible across the MS journey.”
The study results were presented during a late-breaking session at MSToronto2026, the 10th Joint ACTRIMS-ECTRIMS Meeting, and were published simultaneously in The Lancet.
Novartis plans to seek regulatory approval for remibrutinib in RMS globally.