Novartis' remibrutinib lowered annualized relapse rates by 31.2% to 35.2% versus teriflunomide in two late-stage trials for relapsing multiple sclerosis, and the company plans to seek approval worldwide.
The REMODEL-1 and REMODEL-2 studies enrolled 2,007 people across 46 countries. Rates were 0.073 versus 0.112 relapses per patient-year in REMODEL-1 and 0.080 versus 0.116 in REMODEL-2. Novartis said both trials met their primary endpoint with statistically significant results. The findings were presented Friday, Oct. 23, at MSToronto2026 and published the same day in The Lancet.
In a preplanned analysis pooling both trials, remibrutinib was associated with a 29.2% lower risk of disability progression confirmed over six months. Novartis described that result as nominally significant. The reported reduction for progression confirmed over three months was 20.5%, which the company called a positive trend. MRI measures also favored remibrutinib: annualized T2 lesion activity was 0.94 versus 2.71 in REMODEL-1 and 0.82 versus 2.77 in REMODEL-2.
Alanine aminotransferase, a liver enzyme, rose above three times the upper limit of normal in 2.0% of remibrutinib patients and 7.4% of those taking teriflunomide, Novartis reported. The company reported no Hy’s Law cases. Adverse events led to treatment discontinuation in 3.1% of remibrutinib patients and 5.8% of teriflunomide patients. Two people in the remibrutinib group died; investigators judged both deaths unrelated to treatment. One death followed accidental carbon monoxide poisoning and the other was a suicide.
Novartis describes remibrutinib as an oral Bruton’s tyrosine kinase inhibitor designed to modulate immune activity without chronic B-cell depletion. The drug is approved for chronic spontaneous urticaria in the United States and European Union, and for symptomatic dermographism in the United States; those are separate indications from multiple sclerosis.
Reuters reported that analysts had expected relapse-rate reductions of 45% to 60%. The outlet also cited analyst estimates of potential peak sales above $4 billion if remibrutinib is approved for relapsing MS; that figure is not Novartis guidance. The company said it intends to pursue regulatory approval for the MS indication worldwide but did not provide a filing timetable.
